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Wearable Devices for Migraine Prediction

N/A

Waitlist Available

Led By Naraya Kissoon, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial seeks to use smart devices to track and predict headaches, allowing for earlier and more effective treatment.

Who is the study for?

This study is for adults with chronic migraines, who see at least a 50% improvement in headache frequency with their current treatment. Participants should have an average of 4-14 headache days per month and be able to use an iPhone and Apple Watch (provided) to track their health data.

What is being tested?

The trial is testing if wearable devices like the Apple Watch can monitor heart rate and movement to predict when someone might get a migraine. The goal is to see if this tech can warn patients early so they can start treatments sooner.

What are the potential side effects?

Since the intervention involves using eHealth applications on wearable devices, there are no direct medical side effects. However, participants may experience inconvenience or privacy concerns related to continuous health monitoring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

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

uMARS app quality mean score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Custom Phone eHealth ApplicationExperimental Treatment1 Intervention

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.

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