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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.
Secondary outcome measures
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
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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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,063 Total Patients Enrolled
9 Trials studying Migraine
81,786 Patients Enrolled for Migraine
Naraya Kissoon, MDPrincipal InvestigatorMayo Clinic
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I experience headaches every day without a break.I am 18 years old or older.I experience 15 or more headache days a month even with preventative treatment.I have headaches from using too much headache medicine.I can follow the study's procedures and use its devices as required.I agree to keep a daily electronic diary of my headaches.I have been using pain medication daily for more than 3 months.My current headache prevention treatment has cut my headache days by half or more.I experience 4 to 14 headache days monthly despite prevention treatment.I have been diagnosed with chronic migraines.
Research Study Groups:
This trial has the following groups:- Group 1: Custom Phone eHealth Application
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open opportunities for participation in this clinical experiment?
"This investigation, which was initially posted on the 1st of March 2023 and last updated on the 23rd of February 2023, is no longer recruiting participants. Nonetheless, there are currently 179 other trials actively looking for volunteers."
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