A Study of Wearable Devices to Predict Migraines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eHealth Application.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Predict and Track Clinical Outcomes in Chronic Migraine
Overview
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.
Interventions
- 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.
Primary outcome measures
- Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking. [Time frame: 6 months]
Secondary outcome measures (3)
- Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting. [Time frame: 6 months]
- Correlation coefficients of wearable sensor data to headache frequency and severity. [Time frame: 6 months]
- uMARS app quality mean score [Time frame: 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Mayo Clinic Minnesota — Rochester
Identifiers
NCT: NCT05755945 · 22-009944