U.S. patent application number 16/679231 was filed with the patent office on 2021-01-21 for extended digital migraine diary.
The applicant listed for this patent is Alex Dzeda, George McLendon, Joshua Phipps, Shannon Stearman. Invention is credited to Alex Dzeda, George McLendon, Joshua Phipps, Shannon Stearman.
Application Number | 20210020026 16/679231 |
Document ID | / |
Family ID | 1000005313104 |
Filed Date | 2021-01-21 |
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United States Patent
Application |
20210020026 |
Kind Code |
A1 |
McLendon; George ; et
al. |
January 21, 2021 |
EXTENDED DIGITAL MIGRAINE DIARY
Abstract
This document presents a system and method for analyzing
migraine related sensor and diary data to permit the prediction of
migraine headaches for individuals. A mobile device is adapted to
collect and transmit to a server data content from sensors
associated with the mobile device and self-reported data content
indicative of contemporaneous environmental conditions and
individual physical conditions when the individual is suffering
from a migraine headache. The server uses the data content to
develop predictive metrics indicative of a correlation between the
migraine events and the sensor data. The predictive metrics will
provide an alert to a designated individual if it is likely the
individual will experience a migraine within a future time
period.
Inventors: |
McLendon; George; (Davidson,
NC) ; Dzeda; Alex; (Davidson, NC) ; Phipps;
Joshua; (Davidson, NC) ; Stearman; Shannon;
(Davidson, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
McLendon; George
Dzeda; Alex
Phipps; Joshua
Stearman; Shannon |
Davidson
Davidson
Davidson
Davidson |
NC
NC
NC
NC |
US
US
US
US |
|
|
Family ID: |
1000005313104 |
Appl. No.: |
16/679231 |
Filed: |
November 10, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
15343503 |
Nov 4, 2016 |
10473955 |
|
|
16679231 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/6898 20130101;
A61B 5/0002 20130101; A61B 2560/0257 20130101; A61B 5/7275
20130101; G06N 5/04 20130101; A61B 5/746 20130101; A61B 2562/0204
20130101; G16H 50/20 20180101; A61B 2560/0242 20130101; G06N 20/00
20190101; G08B 21/0461 20130101; A61B 5/7282 20130101; A61B 5/748
20130101; A61B 2560/0252 20130101; A61B 5/486 20130101; G08B 31/00
20130101; A61B 2562/029 20130101 |
International
Class: |
G08B 31/00 20060101
G08B031/00; G16H 50/20 20060101 G16H050/20; G06N 20/00 20060101
G06N020/00; G06N 5/04 20060101 G06N005/04; A61B 5/00 20060101
A61B005/00; G08B 21/04 20060101 G08B021/04 |
Claims
1. A system for the prediction of a migraine episode, comprising: a
server in data communication with said mobile device; a data
processor configured within a mobile device in data communication
with one or more sensors collecting sensor data from said one or
more sensors and migraine event data from a user when a user has
indicated that a migraine event has occurred; the data processor
aggregating all sensor data, environmental data, and all migraine
event data and transmitting said aggregated data to the server over
a data communication channel; the server analyzing all aggregated
and collected data from said mobile device to create a prediction
metric; the server applying said prediction metric to the
aggregated and collected data from said mobile device to establish
a prediction score; the server comparing said prediction score to a
pre-determined score value and where said prediction score exceeds
said pre-determined score value creating a migraine prediction
alert message and recommendation; the server transmitting the
migraine prediction alert message and recommendation to said mobile
device to permit the user to take action according to said
recommendation to prevent and/or reduce the severity of a migraine
episode.
2. The system of claim 1, further comprising said data processor
providing one or more data intake screens on a display associated
with said mobile device and presented to a user.
3. The system of claim 1, where sensor data is collected from
sensors comprising a pressure sensor, light sensor, audio sensor,
touch sensor, or any other sensor that may be triggered manually by
an individual, or that may be triggered automatically by changes in
the environment surrounding the individual.
4. The system of claim 3, where the sensor or sensors are in data
communication with a mobile device that is associated with a
user.
5. The system of claim 1, where the migraine prediction alert
message comprises generating daily and hourly migraine forecasts
for each user.
6. The system of claim 1, where the migraine prediction metric is
associated with at least one migraine trigger for an individual
user.
7. The system of claim 1, where the migraine prediction metric is
associated with at least one trigger strength indicators for an
individual user.
8. The system of claim 1, where the environmental data comprises at
least weather data using a patient's recorded location, further
comprising at least humidity, barometric pressure, temperature,
wind speed readings, pollen counts, air pollution and particulate
matter readings, and other environmental conditions at the
patient's location and storing these readings in an electronic
storage data record.
9. The system of claim 1, where said aggregated data is appended to
the existing data in a training/historical dataset to retrain and
improve the predictive models and the individual prediction metric
values for each individual.
10. The system of claim 1, where collected sensor data,
environmental data, and migraine event data input by a user are
combined at the system server to create an entry into a migraine
diary maintained by the system server and associated with an
individual.
11. A method for the prediction of a migraine episode, comprising:
collecting sensor data from a mobile device from one or more
sensors associated with said mobile device and migraine event data
from a user when a user has indicated that a migraine event has
occurred; transmitting all collected sensor data and migraine event
data from a user to a system server; collecting environmental data
at said system server when a user indicates that a migraine event
has occurred; aggregating all sensor data, environmental data, and
all migraine event data within an electronic file storage system
maintained by said system server; analyzing all aggregated and
collected data at said system server from said mobile device to
create a prediction metric; applying said prediction metric at said
system server to the aggregated and collected data from said mobile
device to establish a prediction score; comparing said prediction
score to a pre-determined score value and where said prediction
score exceeds said pre-determined score value creating a migraine
prediction alert message and recommendation; transmitting the
migraine prediction alert message and recommendation to said mobile
device to permit the user to take action according to said
recommendation to prevent and/or reduce the severity of a migraine
episode.
12. The method of claim 11, further comprising said data processor
providing one or more data intake screens on a display associated
with said mobile device and presented to a user.
13. The method of claim 11, where sensor data is collected from
sensors comprising a pressure sensor, light sensor, audio sensor,
touch sensor, or any other sensor that may be triggered manually by
an individual, or that may be triggered automatically by changes in
the environment surrounding the individual.
14. The method of claim 13, where the sensor or sensors are in data
communication with a mobile device that is associated with a
user.
15. The method of claim 11, where the migraine prediction alert
message comprises generating daily and hourly migraine forecasts
for each user.
16. The method of claim 11, where the migraine prediction metric is
associated with at least one migraine trigger for an individual
user.
17. The method of claim 11, where the migraine prediction metric is
associated with at least one trigger strength indicator for an
individual user.
18. The method of claim 11, where the environmental data comprises
at least weather data using a patient's recorded location, further
comprising at least humidity, barometric pressure, temperature,
wind speed readings, pollen counts, air pollution and particulate
matter readings, and other environmental conditions at the
patient's location and storing these readings in an electronic
storage data record.
19. The method of claim 11, where said aggregated data is appended
to the existing data in a training/historical dataset to retrain
and improve the predictive models and the individual prediction
metric values for each individual.
20. The method of claim 11, where collected sensor data,
environmental data, and migraine event data input by a user are
combined at the system server to create an entry into a migraine
diary maintained by the system server and associated with an
individual.
Description
PRIORITY CLAIM
[0001] This Non-Provisional application claims under 35 U.S.C.
.sctn. 120, the benefit of priority as a Continuation-in-Part to
the Non-Provisional application Ser. No. 15/343,503, filed Nov. 4,
2016 and titled "AUTOMATED DIGITAL MIGRAINE DIARY" which is hereby
incorporated by reference in its entirety.
COPYRIGHT NOTICE
[0002] A portion of the disclosure of this patent document contains
material which is subject to copyright protection. The copyright
owner has no objection to the facsimile reproduction of the patent
document or the patent disclosure, as it appears in the Patent and
Trademark Office patent file or records, but otherwise reserves all
copyright rights whatsoever.
BACKGROUND
[0003] Migraine is a chronic, neurological disease characterized by
recurrent moderate to severe headaches often in association with a
number of autonomic nervous system symptoms. Migraines affect
nearly one billion people worldwide, and are more common in women
than men, at 19% and 11% affected, respectively. Examples of
symptoms, by way of non-limiting examples, include nausea,
vomiting, blurred vision, nasal stuffiness, diarrhea, frequent
urination, pallor, sweating, and sensitivity to light, sound, or
smell. Current prevention of migraines includes the use of
medications, nutritional supplements, lifestyle alterations, and
surgery.
[0004] It has been estimated that, worldwide, more than 1 billion
people suffer from migraine headaches. Although much is known about
these maladies, much remains unknown. In the webpaper entitled,
"Migraine: Symptoms and causes" ("Mayo Paper"), the Staff of the
Mayo Clinic relate what is generally known about migraines, and
what, if anything, sufferers may do to mediate, or possibly avoid,
their migraine events. In particular, the Mayo Paper discusses,
briefly, a number of known or suspected triggers.
[0005] In the past, various peer-reviewed clinical studies have
attempted to develop sufficient anecdotal records of actual
migraine events to facilitate confirmation of specific event
triggers. In these studies, the quality of the data tended to be
less than ideal because information relating to each event was
based on after-the-event recollections of the sufferers. More
recently, attempts have been made to facilitate capture, in near
real-time, of migraine related information direct from the
sufferers. However, to be most useful in the search for
environmentally-based triggers, contemporaneous information must
also be collected with respect to those environmental conditions
posited to comprise triggers or, perhaps, just trigger factors.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Certain illustrative embodiments illustrating organization
and method of operation, together with objects and advantages may
be best understood by reference to the detailed description that
follows taken in conjunction with the accompanying drawings in
which:
[0007] FIG. 1 is a view of a system configured to collect
environment and self-reported data during migraine events
consistent with certain embodiments of the present invention.
[0008] FIG. 2 is a view of a communication capability for the
system consistent with certain embodiments of the present
invention.
[0009] FIG. 3a is a view of the flow of data content within a
mobile device configured for data collection consistent with
certain embodiments of the present invention.
[0010] FIG. 3b is a view of the process flow of data analysis
within a server in communication with a mobile device consistent
with certain embodiments of the present invention.
[0011] FIG. 4 is a view of the process flow for the creation of an
alert for transmission to an individual consistent with certain
embodiments of the present invention.
[0012] FIG. 5 is an operational flow diagram for flow for the
creation and optimization of a predictive metric regarding
incipient migraine possibilities for transmission to an individual
consistent with certain embodiments of the present invention.
DETAILED DESCRIPTION
[0013] While this invention is susceptible of embodiment in many
different forms, there is shown in the drawings and will herein be
described in detail specific embodiments, with the understanding
that the present disclosure of such embodiments is to be considered
as an example of the principles and not intended to limit the
invention to the specific embodiments shown and described. In the
description below, like reference numerals are used to describe the
same, similar or corresponding parts in the several views of the
drawings.
[0014] The terms "a" or "an", as used herein, are defined as one or
more than one. The term "plurality", as used herein, is defined as
two or more than two. The term "another", as used herein, is
defined as at least a second or more. The terms "including" and/or
"having", as used herein, are defined as comprising (i.e., open
language). The term "coupled", as used herein, is defined as
connected, although not necessarily directly, and not necessarily
mechanically.
[0015] Reference throughout this document to "one embodiment",
"certain embodiments", "an embodiment" or similar terms means that
a particular feature, structure, or characteristic described in
connection with the embodiment is included in at least one
embodiment of the present invention. Thus, the appearances of such
phrases or in various places throughout this specification are not
necessarily all referring to the same embodiment. Furthermore, the
particular features, structures, or characteristics may be combined
in any suitable manner in one or more embodiments without
limitation.
[0016] The term "about" or "approximately" means within an
acceptable error range for the particular value as determined by
one of ordinary skill in the art, which will depend in part on how
the value is measured or determined, e.g., the limitations of the
measurement system. For example, "about" can mean within 1 or more
than 1 standard deviation, per the practice in the given value.
Where particular values are described in the application and
claims, unless otherwise stated the term "about" should be assumed
to mean an acceptable error range for the particular value.
[0017] The term "sensor pad" refers to a device that, when engaged
by the subject, communicates with the activator. In an embodiment,
the sensor pad is a button, dial, switch, touch screen, or
microphone. In an embodiment, a button is engaged by pressing on
the button. In an embodiment, a dial is engaged by turning the
dial. In an embodiment, the switch is engaged by pressing or
toggling the switch. In an embodiment, a touch screen is a surface
utilizing a touch detection technology. In an embodiment, the touch
detection technology includes resistive, capacitive, infrared,
surface acoustic wave, and near field imaging technologies.
[0018] The terms "individual," "patient," or "subject" are used
interchangeably. None of the terms require or are limited to
situation characterized by the supervision (e.g. constant or
intermittent) of a health care worker (e.g. a doctor, a registered
nurse, a nurse practitioner, a physician's assistant, an orderly,
or a hospice worker).
[0019] "Treating" or "treatment" of a state, disorder or condition
(e.g., migraine) includes: (1) preventing or delaying the
appearance of clinical or sub-clinical symptoms of the disorder
developing in a human that is afflicted with or pre-disposed to the
disorder but does not yet experience or display clinical or
subclinical symptoms of the disorder; and/or (2) inhibiting the
disorder, including arresting, reducing or delaying the clinical
manifestation of the disorder or at least one clinical or
sub-clinical symptom thereof; and/or (3) relieving the disorder,
e.g., causing regression of the disorder or at least one of its
clinical or sub-clinical symptoms; and/or (4) causing a decrease in
the severity of one or more symptoms of the disorder. The benefit
to a subject to be treated is either statistically significant or
at least perceptible to the patient or to the physician.
[0020] Migraines are often triggered by environmental cues, such as
changes in the weather, light, sound, air quality, and odors.
Avoidance of these triggers, in addition to acute symptomatic
control and pharmacological prevention, helps to manage migraines.
Monitoring exposure to potential triggers can help an individual
pinpoint triggers likely to contribute to development of a
migraine.
[0021] Having once collected a sufficiently large set of reliable
event records, together with contemporaneous environmental
condition data, known numerical analysis techniques, such as
regression analysis, can be employed to determine if a
statistically significant correlation exists between the recorded
events and the recorded environmental conditions. As is known, a
statistically significant correlation is indicated by a probability
value of less than 0.05, i.e., that the probability of obtaining
such a correlation coefficient by chance is less than five times
out of 100, so the result indicates the presence of a
relationship.
[0022] Having finally detected a probable trigger, the problem
remains, however, of how to make practical use of this information
better to predict future migraine events on a sufferer-by-sufferer
basis. We submit that what is needed is a migraine prediction
method that is more efficient and effective than the known art.
[0023] In an embodiment, the system herein described may provide a
real-time diagnosis of migraines for patients who have used a
distributed data collection migraine diary process for a
significant amount of time. The migraine dairy application may
import healthkit data (direct/indirect measurements using wearables
as well as self-reported), as well as data collected from sensors
that may be incorporated into the healthkit. Such sensors may
collect and store data regarding migraine intensity, sound,
pressure, temperature, and humidity that exist at the time a
patient indicates a migraine event. Additionally, stress
measurements are also able to be made and incorporated using heart
rate sensors that are attached to the patient.
[0024] In an embodiment, a key to prediction is that in most cases
a single trigger may not result in an episode whereas more than one
trigger can push beyond the threshold to trigger a migraine
episode. In this regard, necessary self-reports are supported by
independent variables like weather, exercise, sleep data and other
self-reported data such as start and stop time for monthly
menstruation cycles. Weather data may be derived from GPS and NOAA
data, where exercise and sleep data may be derived from healthkit
data.
[0025] Often times, patients think that their migraines are
entirely brought on by weather (to the point that some of our users
have moved for supposed better weather areas), or entirely by
eating an onion, etc. While these may be contributing factors,
other information can take this from a hunch to an actual trigger
that can be described as a set of parameters/conditions conducive
for a migraine. In a non-limiting example, there is a widespread
myth that barometric pressure has a direct correlation to headache
onset, and then people get anxious and stress themselves into
having a migraine when they see the pressure is dropping.
[0026] Disclosed herein, in certain embodiments, is a platform for
collecting migraine associated data for an individual who
experiences migraines. The system may generate daily and hourly
migraine forecasts for each patient using neural network models
from the collected migraine associated data. For each patient, the
optimal neural network architecture and weight parameters used in
creating a prediction metric may be at least partially found
through analysis of a patient's historical data and cross
validation testing to learn the particular triggers that may be
associated with the onset of a migraine for a particular
individual. The prediction metric may be composed of particular
triggers associated with a particular individual and the prediction
metric applied to collected environmental, physiological, and
historic data to create a prediction alert and a recommended course
of action to reduce or eliminate an impending migraine headache for
the individual.
[0027] In an embodiment, the migraine associated data collected
contemporaneously with a reported migraine episode from an
individual may comprise environmental data. In an embodiment, the
environmental data is selected from the group consisting of: light,
sound, temperature, air quality, humidity, barometric pressure,
altitude, location data, or any combination thereof. In an
embodiment, the migraine associated data comprises physiological
data. In an embodiment the physiological data is selected from the
group consisting of: heart, activity, sleep data, oxygen saturation
of the blood, and electrodermal activity or any combination
thereof. In an embodiment, the migraine associated data comprises
self-reported data. In an embodiment the self-reported data is
selected from the group consisting of diet, medication, vitamins,
supplements, menstruation status, emotional state, pain intensity,
migraine location, sleep, activity, biomarker, water intake, or any
combination thereof. In an embodiment, the migraine associated data
is recorded when the sensor is triggered automatically.
[0028] In an embodiment, the measurement of migraine associated
data is taken when a sensor is triggered manually. In an
embodiment, the migraine associated data is taken as a baseline
measurement. A sensor may be associated with a mobile device
belonging to a particular individual. A sensor may be a pressure
sensor, light sensor, audio sensor, touch sensor, or any other
sensor that may be triggered manually by an individual, or that may
be triggered automatically by changes in the environment
surrounding the individual and the mobile device associated with
the individual. Sensors may be incorporated into the mobile device,
or may be associated with the mobile device through wired or
wireless connections to the mobile device where each sensor is in
data communication with the mobile device and the sensor data is
captured by the mobile device. In an embodiment, the migraine
associated data is taken instantaneously when the sensor is
triggered. Thus, sensor data may be collected from sensors
comprising a pressure sensor, light sensor, audio sensor, touch
sensor, or any other sensor that may be triggered manually by an
individual, or that may be triggered automatically by changes in
the environment surrounding the individual.
[0029] In an embodiment, the measure of migraine associated data
may be taken over a period of time after the sensor is triggered.
In an embodiment, the baseline measure of migraine associated data
may be recorded one, two, three, four, five, six, seven, eight,
nine, ten, twelve, twenty four, or forty eight times per day,
although these collection timing should in no way be considered
limiting as any consistent timing schedule for collecting and
recording migraine associated data may be followed by each patient.
In an embodiment, the baseline measurement of the migraine
associated data is recorded at an interval specified by the
individual patient.
[0030] In an embodiment, light data comprises a wavelength of light
experienced by the individual. In an embodiment, the wavelength of
light is on the visible spectrum of light (450 nm-750 nm). In other
embodiments, the wavelength of light is not on the visible spectrum
of light (e.g. UV light: 100 nm-400 nm). In an embodiment, light
data comprises an illuminance of light experienced by the
individual where the light, or luminous, intensity is above a
pre-configured level, such as, in a non-limiting example, above 7
lux. Light intensity varies with the time of year, time of day, and
location of the individual, which requires that light intensity
values be regularly sampled and recorded every few minutes, or even
more frequently based upon a user's sensitivity to light levels as
a migraine trigger. The system may activate a light sensor in a
mobile device associated with the user on a relatively regular
schedule to capture the light intensity being experienced by the
user at the time of each collected measurement. The mobile device
may, in a non-limiting example, capture and store a light intensity
measurement once each minute, or any other configured time limit
between measurements, so that relative changes in ambient light
intensity may be identified and reported to the system on a timely
basis.
[0031] In an embodiment, the system may analyze the user's
particular "light intensity" correlation with regard to each
captured light intensity measurement to formulate a migraine
prediction score. If the migraine prediction score is above a
pre-configured threshold level, the system may activate any one or
more of a selected set of proactive responses to reduce or
otherwise affect the possibility of a user experiencing a migraine.
In a non-limiting example, the system may be active to reduce the
intensity of the ambient light in the user's location, change the
hue of a screen display, transmit a command to a room control
facility to close window shades, or perform other actions that
result in reducing the experienced light intensity in the user's
location.
[0032] In an embodiment, sound data comprises a frequency of sound
experienced by the individual. In an embodiment, sound data
comprises an intensity of sound experienced by the individual.
[0033] In an embodiment, temperature data comprises an ambient
temperature experienced by the individual. In an embodiment, the
ambient temperature ranges from 68.degree. F. to 77.degree. F.
(20.degree. C. to 25.degree. C.). In an embodiment, temperature
data comprises an outside temperature. In an embodiment, the
outside temperature is obtained from an external source, for
example from the internet.
[0034] In an embodiment, air quality data comprises a level of a
contaminant in the air. Examples of air contaminants, by way of
non-limiting examples, include ozone, nitrogen dioxide, carbon
monoxide, particulate matter (PM.sub.10 and PM.sub.25), sulphur
dioxide, and hydrogen sulphide. In an embodiment, the air quality
data is obtained from an external source, for example from the
internet.
[0035] In an embodiment, humidity data comprises a humidity
experienced by the individual.
[0036] In an embodiment, barometric pressure data comprises a
barometric pressure experienced by the individual. In an
embodiment, the barometric pressure data comprises whether the
barometric pressure is rising or falling. In an embodiment, the
barometric pressure data is obtained from an external source, for
example the internet.
[0037] In an embodiment, altitude data comprises an altitude of the
individual.
[0038] In an embodiment, location data comprises a location of the
individual. In an embodiment, the location comprises GPS
coordinates of the location. In other embodiments, the location
comprises a zip code, street, city, or combination thereof. In an
embodiment, the location comprises whether the individual is at
home, at work, or another location.
[0039] In an embodiment, heart data comprises a heart rate of the
individual. In an embodiment heart data is an electrocardiogram
(ECG) of an individual. In an embodiment, heart data comprises
whether the individual has an arrhythmia. In an embodiment, heart
data comprises heart rate variability.
[0040] In an embodiment, activity data comprises a movement. In an
embodiment, the movement is the distance an individual has moved
during a day. In an embodiment the distance moved is determined for
different periods of the time. Examples of periods of time, by way
of non-limiting examples, include general (e.g. morning, afternoon,
evening, night) and every hour (e.g. 8-9 am, 9-10 am, and so
forth). In an embodiment, the movement is a number of steps an
individual has taken during the day or during a period of time. In
an embodiment, activity data comprises self-reported data regarding
an activity in which the individual has participated. In an
embodiment, self-reported activity data further comprises the
length of time spent participating in the activity. In an
embodiment, the activity is chosen by the individual from a list.
Example of activities, by way of non-limiting examples, include
archery, badminton, baseball, basketball, biking, bowling,
canoeing, cricket, cross-country skiing, curling, fencing,
football, golf, gymnastics, hiking, hockey, horseback riding,
kayaking, martial arts, rollerblading, rowing, running, skating,
skiing, snowboarding, snowshoeing, soccer, swimming, tennis,
volleyball, weightlifting, and wrestling. In an embodiment, the
individual can manually add an activity to the list.
[0041] In an embodiment, sleep data comprises an amount of sleep an
individual has experienced. In an embodiment, the amount of sleep
is automatically recorded or is self-reported. In an embodiment,
sleep data comprises a quality of sleep for the individual. In an
embodiment, quality of sleep is automatically recorded. In an
embodiment, the quality of sleep comprises the amount of movement
during sleep. In an embodiment, the quality of sleep comprises the
amount of time spent in each stage of sleep. In an embodiment, the
quality of sleep comprises the stage of sleep during which an
individual awakens. In an embodiment, the quality of sleep is
self-reported. In an embodiment, self-reported quality of sleep
data comprises a scale of the quality of sleep the individual feels
they experienced. A non-limiting example of a scale of quality of
sleep is scale of 1 to 5, wherein 1 is a very restful sleep and 5
is a very unrestful sleep. In an embodiment, self-reported quality
of sleep data comprises illustrations of facial expressions wherein
the facial expressions are representative of the quality of sleep
an individual feels they experienced.
[0042] In an embodiment, oxygen saturation of the blood comprises
an oxygen level of the blood.
[0043] In an embodiment, electrodermal activity comprises a measure
of galvanic skin response.
[0044] In an embodiment, dietary data comprises whether an
individual consumed a meal (e.g. breakfast, lunch, dinner) or a
snack. In an embodiment, the dietary data comprises a time the meal
or snack was consumed. In an embodiment, the dietary data comprises
a type of food or beverage consumed. In an embodiment, the dietary
data comprises a time a food or beverage was consumed. In an
embodiment, the dietary data comprises an amount of the food or
beverage consumed. In an embodiment, the type of food or beverage
consumed chosen by the individual from a list. Examples of types of
food and beverages in the list, by way of non-limiting examples,
include chocolate, alcoholic beverages (e.g. red wine, white wine,
beer, liquor), caffeine containing beverages (e.g. coffee, soda,
tea), avocados, beans (e.g. string, navy, kidney, lima), pickled
food (e.g. cucumbers, eggs, beets, olives, peppers), bananas,
bread, cheese (e.g. cheddar, blue, Brie, aged cheese), chili
pepper, pork, soy-based foods, processed meat (e.g. bacon, hot
dogs, deli meats, pepperoni, sausage, jerky), nuts, citrus fruits,
dried fruits (e.g. prunes, figs, apricots), vinegar (e.g. red
vinegar, balsamic vinegar), apples, pears, plums, apple juice,
cider, sour cream, milk, and sweeteners (e.g. aspartame). In an
embodiment, the individual can manually add a food or beverage item
to the list.
[0045] In an embodiment, supplement data comprises whether an
individual is currently taking a supplement. In an embodiment, the
supplement data further comprises a time of day the supplement is
taken. In an embodiment, the supplement data further comprises an
amount of the supplement taken. In an embodiment, the supplement
data is a type of supplement taken. In an embodiment, the type of
supplement taken is chosen by the individual from a list. Examples
of supplements in the list, by way of non-limiting examples,
include vitamin D, vitamin E, vitamin A, vitamin B2, vitamin B3,
vitamin B6, vitamin B12, and magnesium, melatonin, butterbur,
feverfew, and coenzyme Q10. In an embodiment, the individual can
manually add a supplement to the list.
[0046] In an embodiment, emotional state data comprises the
emotional state of an individual. In an embodiment, the emotional
state is chosen by the individual from a list. Examples of
emotional states in the list, by way of non-limiting examples,
include happy, excited, angry, depressed, anxious, confused, and
stressed. In an embodiment, the individual can manually add an
emotional state to the list. In an embodiment, the emotional state
comprises illustrations of facial expressions representing the
emotional state.
[0047] In an embodiment, pain data comprises the level of pain of a
migraine. In an embodiment, the level of pain of a migraine
comprises a scale. A non-limiting example of a scale of pain
intensity is scale of 1 to 5, wherein 1 is no pain and 5 is severe,
debilitating pain. In other embodiments, the level of pain of a
migraine data comprises illustrations of facial expressions wherein
the facial expressions are representative of the level of pain an
individual is feeling.
[0048] In an embodiment, location of a migraine data comprises the
area of the body where an individual feels migraine pain. In an
embodiment, the location of the migraine data comprises an
illustration of a body with various regions highlighted where
migraine pain can be experienced wherein the individuals selects
the illustration best representing where pain is being experienced.
In other embodiments, the location of the migraine data comprises
an illustration of a body showing a plurality of points where
migraine pain can be experienced wherein the individual selects the
points where pain is being experienced. In other embodiments, the
location of the migraine comprises an illustration of a body
showing a plurality of regions where migraine pain can be
experienced wherein the individual selects the regions where pain
is being experienced.
[0049] In an embodiment, biomarker data comprises genetic,
proteinic, hormonic, or other biological data. In an embodiment,
genetic data comprises the presence of a single nucleotide
polymorphism (SNP), insertion, deletion, inversion, microsatellite,
or copy number variant. Examples of SNPs associated with migraines
include, but are not limited to, rs1835740, rs1043994, rs1042838,
rs2651899, rs10166942, and rs11172113. In an embodiment, proteinic
data comprises the presence or quantity of a protein biomarker.
Non-limiting examples of protein biomarkers include, but are not
limited to: C-reactive protein (CRP), calcitonin gene-related
protein (cGRP), or adipokines (e.g. adiponectin). In an embodiment,
the hormonic data comprises the presence or quantity of a hormone.
Examples of hormones include, by way of non-limiting examples,
testosterone, progesterone, and estrogen. In an embodiment, the
other biological data comprises the level in the individual of a
non-protein biomarker. Examples of non-protein biomarkers include,
but are not limited to, vitamin D, blood glucose, lipids (e.g.
ceramides), insulin, or homocysteine. In an embodiment, the
biomarker is determined from a bodily fluid sample from the
individual, such as from the blood, saliva, urine, or stool. In an
embodiment, the individual reports biomarker data from a family
member.
[0050] In an embodiment, the system and method can be described as
for each individual in the creation of a prediction metric that is
relevant for each individual, finding the optimal combination of
connected nonlinear functions that may transform observed input
parameters as herein described utilizing the prediction metric as
applied to the collected gathered information, both gathered from
sensor data and self-reported information, into a binary output
target variable. The target variable is the binary outcome of has
migraine/no migraine. The observed input parameters include
collected weather data, menstrual cycles, self-reported migraine
diary entries, and collected health data. The system may collect
the weather data using a patient's recorded location, and use the
humidity, barometric pressure, temperature, and wind speed readings
(among others) at the patient's location to pass into the
algorithms. In a non-limiting example, menstrual cycle data is
collected by a patient entering their start and end times of the
menstrual cycle into the migraine diary. The system transforms all
collected menstrual cycle data into a binary variable (does have
period/does not have period). The menstruation status data further
comprises the current day of the individual's menstrual cycle,
wherein day 1 is the day menstruation began.
[0051] In an embodiment, as the system collects the data from the
patients, the newly collected information is appended to the
existing data in the training/historical dataset, which allows the
system to retrain and improve the predictive models and the
individual prediction metric values. To make a real-time diagnosis,
the system collects all the current observed input variables,
creates the prediction metric that is associated with each
individual, and passes this data to the predictive models to run
the calculation of the output variable classification. This
classification shows the probability of the individual having a
migraine in the requested time frame.
[0052] Turning now to FIG. 1, this figure presents a view of a
system configured to collect environment and self-reported data
during migraine events consistent with certain embodiments of the
present invention. In an exemplary embodiment, the migraine
analysis system 10 may utilize a mobile device 12, where the mobile
device 12 may consist of any device having a data processor that
may establish network communication and two-way data communication
with a server 14 exterior to the mobile device 12. Thus, by way of
illustration and not limitation, the mobile device 12 may be a
portable computer, laptop, smart phone, smart watch, tablet, iPad,
or any other mobile device. The mobile device 12 and the server 14
are connected through a network cloud 16 where data may be
communicated to the cloud 18 and the cloud may then transfer all
communications 20 from the mobile device to the server 14. The
mobile device 12 may comprise a central processing unit (CPU) 22
that is active to operate the collection of data from the mobile
device 12. The mobile device 12 may also comprise an internal
electronic memory 24 having the capacity to store and activate an
operating system 26, provide storage and operational memory space
for the migraine diary data collection application 28, and provide
storage for all data captured by the mobile device 12 during
operation. A display 32 permits a user to view the data being
collected by the mobile device 12 and communicated from the mobile
device 12 to the network cloud 16. The mobile device 12 may also be
activated by a touch position 36 accessible to a user of the
device.
[0053] Turning now to FIG. 2, this figure presents a view of a
communication bus providing data communication capability for the
system consistent with certain embodiments of the present
invention. In an exemplary embodiment, the system presents a data
communication bus within the server 14 that is active to collect
the incoming data communication from a mobile device and provide
access to that data both to the analytic and predictive software
processes operational within said server 14 and to an individual
accessing the server 14.
[0054] Turning now to FIG. 3a, this figure presents a view of the
flow of data content within a mobile device configured for data
collection consistent with certain embodiments of the present
invention. In an exemplary embodiment, a first process may be
active within the mobile device 12 to permit the activation and
data collection from one or more sensors that are associated with
said mobile device 12. A second process may be active within the
mobile device 12 to permit the capture of migraine event records
and the transmission of the captured migraine event records to a
system server 14 through an established communication channel 34
active within the mobile device 12.
[0055] The first and second processes may be activated by a user
through the selection of an activation touch position 36 located on
the mobile device 12. Once activated, the first process is active
to collect sensor signals and record the information from the
sensor signals to an electronic storage element within the mobile
device 12. The collected and stored sensor signals may then be
transferred from the electronic storage element of the mobile
device 12 to a system server 14 through an established
communication channel 34 active within the mobile device 12.
Utilizing the collection and storage capabilities of the first and
second processes, the mobile device 12 permits a patient to capture
migraine event information actively while the mobile device
automatically captures sensor information that is relevant to the
time that the migraine event occurred. The migraine sensor
information and event records input by a user are combined at the
system server 14 to create an entry into a migraine diary
maintained by the system server and associated with the user.
[0056] Turning now to FIG. 3b, this figure presents a view of the
process flow of data analysis within a system server in
communication with a mobile device consistent with certain
embodiments of the present invention. In an exemplary embodiment, a
mobile device 12 transmits all collected sensor data and user input
records to the system server 14 at the time of the occurrence of a
migraine event for the user.
[0057] Upon receipt of a data communication containing a sensor
signal data record from the mobile device, the system server may
record the sensor signal data record in an electronic storage
device and interrogate the mobile device 12 through the
communication channel as to whether additional sensor signals are
to be transmitted from the mobile device 12. If additional sensor
signals containing sensor data records are received the system
server stores those received data records in the electronic storage
device. The interrogation and storage of received sensor signal
data records continues until all sensor signal data records for a
particular migraine event are received by the system server and
stored in the record created in the electronic storage device. The
system server may also receive migraine event data records from the
mobile device 12 and store the received migraine event data records
in the record created in the electronic storage device for the
particular time and particular user, combining the migraine event
data records with the sensor signal data records and collected
environmental data readings to create a complete migraine diary
record event for a particular event and particular user.
[0058] The system server may also initiate a process to develop a
predictive metric for each individual based upon the migraine diary
data record entries for each user. To develop a predictive metric
for the condition of migraine/no migraine, the system server
process utilizes input parameters that exist at the day and time
that a user indicates a migraine event and includes collected
weather data, menstrual cycles, and collected health data where the
predictive metric includes the personalized reactions of an
individual to all environmental and health conditions to produce a
predictive metric that creates an indication of how these
environmental and health conditions affect the individual to
contribute to a migraine episode, or contribute to the severity of
a migraine once it occurs. The system server collects weather data
using a patient's recorded location, collecting the humidity,
barometric pressure, temperature, wind speed readings, pollen
counts, air pollution and particulate matter readings, and other
environmental conditions (among others) at the patient's location
and storing these readings in the electronic storage data record.
These readings may then be combined with the sensor data record and
user migraine event data records. The combined data records in
combination with the created prediction metric may then be utilized
by migraine detection algorithms active in the system server to
create a tentative prediction for each individual.
[0059] Additional data records such as menstrual cycle information
is collected for female patients. The menstrual cycle data is
collected by a patient entering their start and end times of the
menstrual cycle. The system server process transforms this
information into a binary variable (does have period/does not have
period). This information is appended to the migraine diary record
to optimize the predictive metric for users for whom this
information applies.
[0060] In a third process in the system server, to make a real-time
prediction of a migraine episode occurrence for a particular user,
the system server collects all the current observed input variables
for a user and passes this data into the predictive models. To
determine the predictive metric for a particular individual, the
system server selects a subset of the sensor signal data records
and user input data records and utilizes this subset to run the
calculation of the output variable classification for a migraine
episode, and/or the severity of a migraine episode, as a predictive
metric. This predictive metric is used to analyze the collected
data by the predictive model to indicate the probability of the
user having a migraine in a requested time frame. If the result of
the predictive model for a particular user indicates that the user
may experience a migraine in a near future timeframe. The system
server may formulate a migraine prediction alert message and
transmit that message, along with a recommended course of action to
the affected user to prevent the migraine or reduce the severity of
the migraine in a migraine episode.
[0061] As data is collected from the patients, all updated and new
data is appended to the training/historical migraine diary dataset
for all monitored individuals. The training/historical migraine
diary dataset, which encompasses all current and historical records
for all users, permits the system server process to retrain and
improve the migraine predictive models.
[0062] Turning now to FIG. 4, this figure presents a view of the
process flow for the creation of a migraine prediction metric for
transmission to an individual and transmitting the alert to the
mobile device associated with an individual consistent with certain
embodiments of the present invention. In an exemplary embodiment, a
reporting process is active in the system server 14 to formulate a
migraine prediction metric for an individual. The migraine
prediction metric is transmitted from the system server 14 to a
mobile device 12 that is associated with the individual.
[0063] A communication process is active within the mobile device
12 to receive communications, including migraine prediction
metrics, from the system server 14. Upon receipt of a migraine
prediction metric, the mobile device 12 initiates a process that
selects a subset of the sensor signals and the reported migraine
event record data that are associated with a particular individual.
The process then applies the received migraine prediction metric to
the combined sensor signals and reported migraine event record data
to create a migraine prediction for the particular individual. In
an alternative embodiment, the migraine prediction metric may be
applied to the sensor signals associated with a particular
individual to create a migraine prediction score for the particular
individual.
[0064] The process in the mobile device then evaluates the created
migraine prediction score against a pre-determined score value,
where the score value represents the likelihood of a particular
individual experiencing a migraine in the near future. If the
migraine prediction score for the individual exceeds the
pre-determined score value, the particular individual is likely to
experience a migraine within a short time frame. If the migraine
prediction score for the individual does not exceed the
pre-determined score value, the particular individual is not
expected to experience a migraine within a short time frame. When
the individual is expected to experience a migraine because the
migraine prediction score exceeds the pre-determined score value, a
migraine alert message is formulated along with a recommendation
for preventing, delaying, or otherwise preparing for a migraine
episode and displayed to the particular individual on the display
screen of the mobile device. The migraine prediction alert message
and recommendation are transmitted by the system server to any
mobile device associated with the user to permit the user to take
action according to the recommendation to prevent and/or reduce the
severity of a migraine episode. Thus, the particular individual
associated with the mobile device is alerted to an incipient
migraine event to permit the particular individual to take action
to change behavior or perform other prophylactic measures to keep
the migraine headache from occurring, or keep the severity of the
migraine episode to as low a pain level experience as the
recommended migraine prophylactic measures will allow.
[0065] Turning now to FIG. 5, this figure presents an operational
flow diagram for flow for the creation and optimization of a
predictive metric regarding incipient migraine possibilities for
transmission to an individual consistent with certain embodiments
of the present invention. In this embodiment, updating a prediction
metric to optimize the ability of the metric to provide migraine
inception recommendations may occur in a system server 14 or as a
process within a mobile device 12 associated with a particular
user.
[0066] In an embodiment, the Predictive Metric Process, suitable
for implementation in a system server 14 or as a process within a
mobile device 12 associated with a particular user, initially to
identify each of a plurality of possible trigger(s), T.sub.N, of a
particular user, and, thereafter, to become increasingly sensitive
to each identified trigger. To enable this process, the memory in
the Server 14 (or Mobile Device 12) is adapted, for each
individual, to store N trigger strength indicators, S.sub.N, each
corresponding to a respective one of the T.sub.N triggers. The
process is active to collect and periodically analyze, using known
regression analysis techniques, the user's event records and
associated environmental sensor signals to develop a predictive
metric for each possible trigger. The predictive metric is analyzed
in coordination with the combined sensor signals and reported
migraine event record data for each individual to create one or
more triggers and/or trigger strength indicators to formulate the
migraine prediction message and the recommended course of action to
prevent and/or reduce the severity of a migraine episode for the
particular individual.
[0067] Once the metric of a particular trigger, e.g., Tx, exceeds a
selected minimum threshold, the system sets a respective one of the
trigger strength indicators, Sx, to a predetermined minimum value
to indicate that potential trigger Tx might, in time, prove to be a
trigger in fact. Thereafter, as additional events (with associated
sensor signals) are recorded, the system may continue to improve
the predictive metric. When the system detects a strengthening of
the prediction metric for a trigger Tx, the process is active to
increase the respective trigger strength indicator Sx. Once the
strength of trigger strength indicator Sx has surpassed a
predetermined significance threshold, the trigger Tx is considered
as having been proven, and, thereafter, the system may cast
predictions with respect to trigger Tx.
[0068] In an embodiment, the system may continue to recursively
refine the developed predictive metric for trigger T.sub.N until
the respective strength indictor S.sub.N attains a maximum strength
value. In a non-limiting example, the predictive metric process
represents an adaptive alternative to the binary approach discussed
above, where the metric was considered to be either significant or
not, based on purely probabilistic criteria. In an embodiment, each
trigger may likely require care in the selection of the several
thresholds that are used in the analysis of whether the strength of
the prediction metric is acceptable, in the calibration of the
strength indicators and with respect to the parameters related to
the decision points in the flow.
[0069] While certain illustrative embodiments have been described,
it is evident that many alternatives, modifications, permutations
and variations will become apparent to those skilled in the art in
light of the foregoing description.
* * * * *