Who is eligible for clinical trial NCT05755945?

Participants must meet protocol criteria for Migraine. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05755945 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-07

A Study of Wearable Devices to Predict Migraines (NCT05755945)

🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).

Location: Mayo Clinic Minnesota — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mayo Clinic Minnesota — Rochester, Minnesota

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗