Wearable Devices for Migraine Prediction

Overseen By Julianna Ethridge

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opioids, NSAIDs, Acetaminophen

Disqualifiers: Chronic daily headache, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether smart devices like an Apple Watch can predict migraines by tracking heart rate and movement. The goal is to determine if this data can indicate when headaches might worsen, potentially leading to earlier and more effective treatments. Suitable participants experience migraines, have seen improvement with current prevention methods, and have 4 to 14 headache days a month. Participants must be comfortable using an iPhone and Apple Watch and willing to log their headaches daily in a digital health app. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance migraine management for many.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using daily opioids or other daily pain medications, you may not be eligible to participate.

What prior data suggests that these wearable devices are safe for tracking migraines?

Research has shown that digital health apps, including those for migraines, are generally safe for users. One study compared a prescription-required migraine app to a regular app and found no major safety issues, indicating that using an app to track migraines is usually well-tolerated.

Another study found that migraine apps can improve communication between patients and doctors, suggesting they are safe for regular use without causing harm.

However, some headache apps have shared user information with other companies, posing a potential privacy risk. While this does not affect physical safety, it is an important consideration when using these apps.

Overall, studies suggest that using an eHealth app to predict migraines is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to predict and potentially prevent migraines using wearable technology. Unlike traditional migraine treatments that mainly focus on relieving symptoms with medications, this approach uses an Apple Watch and an eHealth application to monitor and analyze data continuously. This method could help identify patterns or triggers before a migraine starts, offering a proactive option to manage migraines more effectively.

What evidence suggests that this wearable device is effective for predicting migraines?

Previous studies have shown that wearable sensors can predict migraine attacks with over 84% accuracy by using sleep data. By tracking sleep patterns, these devices often indicate when a migraine is likely. Research also shows that smartphone apps can reduce the number of migraine days by reminding users to take their medication on time. One study found that a mobile app improved communication with healthcare providers and offered educational content, aiding in better migraine management. In this trial, participants will use a custom eHealth application with an Apple Watch to predict and manage migraines effectively, leveraging these previous findings. ^{1 2 6 7 8}

Who Is on the Research Team?

Naraya Kissoon, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

I can follow the study's procedures and use its devices as required.

I agree to keep a daily electronic diary of my headaches.

Exclusion Criteria

I experience headaches every day without a break.

Inability or unwillingness of individual or legal guardian/representative to give written informed consent

I experience 15 or more headache days a month even with preventative treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use wearable devices and complete daily questionnaires to track and predict migraine occurrences

6 months

Daily self-reporting via app

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• eHealth Application

Trial Overview

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.

How Is the Trial Designed?

Group I: Custom Phone eHealth Application Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A study involving 288 migraine patients using the RELAXaHEAD app revealed that users value the ability to track a wide range of headache-related information, including characteristics, medications, and sleep patterns, beyond standard input options.

Patients also expressed a desire to monitor coexisting conditions, adherence to behavioral therapy, and patterns of migraine triggers and relief, indicating that comprehensive tracking features can enhance user engagement and potentially improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding What People With Migraine Consider to be Important Features of Migraine Tracking: An Analysis of the Utilization of Smartphone-Based Migraine Tracking With a Free-Text Feature. Minen, MT., Jaran, J., Boyers, T., et al.[2021]

Citations

1.

ehv.health

ehv.health/project/wizermed/

Wizermed - eHV

Addressing this pressing issue, Wizermed introduces “Migraine Predict,” an innovative AI-driven mobile application poised to revolutionize migraine management.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12215570/

A Prescribed Digital Health App and Number of Migraine Days

This randomized clinical trial compares the effectiveness of a prescribable digital health app with a control app to reduce the number of migraine days.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04984720

Efficacy of Smartphone Based Digital Application in ...

Regular pill reminders issued through smartphone based applications can improve medication adherence and thus improve headache outcomes. Though smartphone ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11964953/

Mobile App-Based Interactive Care Plan for Migraine

The MICP facilitates remote assessment of adult patients with migraine, educational content delivery, and care team communication.

5.

withpower.com

withpower.com/trial/wearable-devices-for-migraine-prediction-c0b95

Wearable Devices for Migraine Prediction

Preliminary research using wearable sensors shows that sleep data can predict migraine attacks with over 84% accuracy, although results vary between individuals ...

6.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/03331024251348651

A narrative review of app- and internet-delivered headache ...

There is an increasing trend in the use of the internet and smartphone applications to deliver headache interventions.

7.

researchgate.net

researchgate.net/publication/389052209_Migraine_Generative_Artificial_Intelligence_based_on_Mobile_Personalized_Healthcare

Migraine Generative Artificial Intelligence based on Mobile ...

Therefore, this paper can provide insights into the state of art in mobile based personalized healthcare system to recommend future paths, for ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6347475/

An Analysis of Headache/Migraine Applications

Headache apps shared information with third parties, posing privacy risks partly because there are few legal protections against the sale or disclosure of data.