A Study of Wearable Devices to Predict Migraines

Last updated: May 6, 2025
Sponsor: Mayo Clinic
Overall Status: Active - Enrolling

Phase

N/A

Condition

Headaches

Chronic Pain

Oral Facial Pain

Treatment

eHealth Application

Clinical Study ID

NCT05755945
22-009944
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 years and older (no upper age limit defined)

  • History of chronic migraine as defined by the International Headache Society'sInternational Classification of Headache Disorders (3rd edition).

  • Response to current preventative therapy with ≥ 50% improvement in the frequency ofheadache days when compared to baseline

  • 4 to 14 average number of total headache days per month during peak efficacy ofpreventative therapy

  • Ability to understand study procedures and to comply with them for the entire lengthof 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

Exclusion Criteria:

  • Chronic daily headache with no periods of headache freedom.

  • ≥ 15 average number of headaches days per month during peak efficacy of preventativetreatment.

  • Medication overuse headache as defined by the International Headache Society'sInternational Classification of Headache Disorders (3rd edition).

  • Daily opioid use for > 3 months (e.g., hydrocodone, oxycodone, fentanyl patch) orother daily analgesic use for chronic pain disorders (e.g., NSAIDS oracetaminophen).

  • Inability or unwillingness of individual or legal guardian/representative to givewritten informed consent.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: eHealth Application
Phase:
Study Start date:
February 24, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Mayo Clinic Minnesota

    Rochester, Minnesota 55905
    United States

    Site Not Available

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