A Study of Wearable Devices to Predict Migraines

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05755945
• Other study ID #: 22-009944
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	uMARS app quality mean score	Quality of the custom phone app integrated with smart watches as assessed by the validated uMARS.	6 months