NCT05755945

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Feb 2023Jun 2026

First Submitted

Initial submission to the registry

February 23, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

3.3 years

First QC Date

February 23, 2023

Last Update Submit

May 6, 2025

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    6 months

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

    6 months

  • uMARS app quality mean score

    6 months

Study Arms (1)

Custom Phone eHealth Application

EXPERIMENTAL

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

Interventions

eHealth ApplicationOTHER

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.

Custom Phone eHealth Application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Naraya Kissoon, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

February 24, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)