A Study of Wearable Devices to Predict Migraines

A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Predict and Track Clinical Outcomes in Chronic Migraine

The purpose of this research is to determine if data from smart devices, including heart rate and movement during sleep and wake times, will be able to track headaches and predict recurrence and exacerbations (make worse). This use of this information may in the future allow patients earlier and more effective treatments if these devices can help predict when the headaches may occur.

Study Overview

• Status: Enrolling by invitation
• Conditions: Migraine
• Intervention / Treatment: Other: eHealth Application

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years and older (no upper age limit defined)
• History of chronic migraine as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition).
• Response to current preventative therapy with ≥ 50% improvement in the frequency of headache days when compared to baseline
• 4 to 14 average number of total headache days per month during peak efficacy of preventative therapy
• Ability to understand study procedures and to comply with them for the entire length of the study and use study devices as outlined in protocol.
• Patient agrees to maintain a daily electronic headache diary.
• Proficient in the use of electronic devices including Apple HomeKit and Apple Watch. - Subjects owns an iPhone with iOS 16 or later operating system installed on iPhone. Apple watch series 8 with watch OS6 or later will be provided by the study.

Exclusion Criteria:

• Chronic daily headache with no periods of headache freedom.
• ≥ 15 average number of headaches days per month during peak efficacy of preventative treatment.
• Medication overuse headache as defined by the International Headache Society's International Classification of Headache Disorders (3rd edition).
• Daily opioid use for > 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) or other daily analgesic use for chronic pain disorders (e.g., NSAIDS or acetaminophen).
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Custom Phone eHealth Application; Subjects diagnosed with migraine headaches and have had a positive response to prevention treatments for migraine, will wear an Apple Watch whenever possible (including during sleep) and complete application questionnaires on the eHealth application daily.	Other: eHealth Application; Custom phone application that integrates data from smart watch. Subjects will complete daily "To-Do-Lists" where data will be collected on if they had a headache in the past 24 hours, severity of headache, and any analgesics used to treat the headache.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.	Percentage accuracy of fit with AUC of the ROC curve for factors from data collected from custom phone app integrated with smart devices to track headache frequency and severity.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting.	Percentage accuracy of fit with AUC of the ROC curve for data from custom phone app integrated with smart devices to forecast periods of increased headache likelihood.	6 months
Correlation coefficients of wearable sensor data to headache frequency and severity.	Correlation of novel physiological clinical outcome data (e.g., time in bed, average sleep time, stand time, exercise time, move time, walking distance, running distance, estimated six-minute walk, steps per day, heart rate, heart rate variability) to monthly headache days, moderate to severe monthly headache days, analgesic use, MIDAS, and HIT-6.	6 months
uMARS app quality mean score	Quality of the custom phone app integrated with smart watches as assessed by the validated uMARS.	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Naraya Kissoon, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 22-009944

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No