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OpenTrials
Enrolling by Invitation

NCT Number: NCT05755945

A Study of Wearable Devices to Predict Migraines

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eHealth Application

Other

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.

Primary outcomes

  1. Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.

    Time frame: 6 months

    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.

Secondary outcomes

  1. Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting.

    Time frame: 6 months

    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.

  2. Correlation coefficients of wearable sensor data to headache frequency and severity.

    Time frame: 6 months

    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.

  3. uMARS app quality mean score

    Time frame: 6 months

    Quality of the custom phone app integrated with smart watches as assessed by the validated uMARS.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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