NCT03762902

Predicting Migraine Attacks Based on Environmental and Behavioral Changes as Detected From the Smartphone

The Relation Between Analyzed Sensory Data of the Smartphone and Migraine Attacks, Recorded by Individuals Who Suffer From Episodic Migraine

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Lifegraph Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is conducted at the Henry Ford Health System with Lifegraph's behavioral monitoring technology, to examine the relation between migraine attacks and behavioral and environmental changes as detected from the smartphone sensors. The investigators hypothesize that Lifegraph's technology can predict the occurrence of migraine attacks with high precision.

Detailed description

Migraine attacks can damage quality of life and lead to missed work days if not treated in time. These attacks last for about 4-72 hours, accompanied by headache and other symptoms. The time window for early intervention, which can potentially reduce the severity of an attack, lasts 2-48 hours before symptoms are starting to appear (10 hours on average). This time window is defined in the literature as the prodromal phase, when intervention during this phase can allow early treatment to improve the patient's condition and reduce the intensity and duration of the attack. Migraine attacks and the prodromal phase can be characterized by one or more behavioral or environmental symptoms, either causal or resultant. Some of them can be passively measured by the smartphone usage, such as changes in sleep, physical activity and weather. Lifegraph's smartphone application runs in the background of the subjects' personal smartphone, collects data passively and automatically, while rigorously maintaining privacy and with no effect to the daily use. Proprietary machine-learning algorithms analyze the collected data and turn it into behavioral channels, such as activity, sleep and mobility. The technology learns the personal routine of each user and detects changes in his/her behavioral patterns that can indicate an upcoming migraine. Eligible subjects will meet a neurologist, sign an informed consent, fill an initial questionnaire and install the Lifegraph application on their smartphone. The application requires a one-time registration process. During the study, subjects will self-report migraine attacks they experience through the smartphone application. Each report will include start time, end time and pain intensity. Data will be analyzed during the study in order to learn each subject's behavior and his/her migraine attacks. Subjects will be blinded to the app's migraine predictions to avoid expectancy bias.

Conditions

• Migraine Disorders
• Headache Disorders
• Headache Disorders, Primary
• Brain Diseases
• Central Nervous System Diseases
• Nervous System Diseases

Timeline

• Start date: 2019-04-30
• Primary completion: 2019-08-01
• Completion: 2019-09-01
• First posted: 2018-12-04
• Last updated: 2019-09-13

Locations

2 sites across 1 country: United States