Clinical trial NCT05755945: A Study of Wearable Devices to Predict Migraines
Official title: A Prospective Feasibility Study Evaluating the Use of Wearable Devices to Predict and Track Clinical Outcomes in Chronic Migraine
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Migraine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


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.

Primary outcomes:
measure: Percentage accuracy of fit with AUC of the ROC (receiver operating characteristics) curve (%) for headache tracking.
timeFrame: 6 months
Secondary outcomes:
measure: Percentage accuracy of fit with AUC of the ROC curve (%) for headache forecasting.
timeFrame: 6 months
measure: Correlation coefficients of wearable sensor data to headache frequency and severity.
timeFrame: 6 months
measure: uMARS app quality mean score
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Naraya Kissoon, MD
role: PRINCIPAL_INVESTIGATOR
References: