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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the eHealth Application treatment 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. This suggests that wearable devices, as part of an eHealth application, could potentially help in early detection of migraines, allowing for timely preventive measures. ^{1 2 3 4 5}

Is it safe to use wearable devices for migraine prediction?

There is no specific safety data available for wearable devices used in migraine prediction from the provided research articles. ^{6 7 8 9 10}

How does the wearable device treatment for migraine prediction differ from other treatments?

This treatment is unique because it uses wearable devices to predict migraine attacks by analyzing sleep data, allowing for timely preventive measures. Unlike traditional treatments that focus on alleviating symptoms during an attack, this approach aims to detect and potentially prevent migraines before they occur. ^{1 3 6 7 8}

Research Team

Naraya Kissoon, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I am 18 years old or older.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Using Sleep Time Data from Wearable Sensors for Early Detection of Migraine Attacks. [2018]

2. England pubmed.ncbi.nlm.nih.gov

E-diary use in clinical headache practice: A prospective observational study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Development and validation of the ID-EC - the ITALIAN version of the identify chronic migraine. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Introduction of a smartphone based behavioral intervention for migraine in the emergency department. [2023]

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

An observational study of self-reported migraine triggers and prospective evaluation of the relationships with occurrence of attacks enabled by a smartphone application (App). [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of naratriptan versus naproxen on daily functioning in the acute treatment of migraine: a randomized, double-blind, double-dummy, crossover study. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Towards an objective quantitative assessment of daily functioning in migraine: a feasibility study. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Burden of Migraine in Europe Using Self-Reported Digital Diary Data from the Migraine Buddy© Application. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Preferences and User Experiences of Wearable Devices in Epilepsy: A Systematic Review and Mixed-Methods Synthesis. [2022]