Clinical trial NCT06862544: Migraine Research with Smartwatch Application
Official title: Migraine Research with Smartwatch Application (MIRA) - a Prospective Migraine Study with Wearables
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Migraine
Keywords: Migraine
Headache
Smartwatch
Wearables
Digital health tools
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with episodic or chronic migraine 18 years or older

Brief summary: This clinical, prospective study aims to evaluate the effectiveness of wearable technology in capturing real-time data to assess disease activity in patients with episodic or chronic migraine undergoing different therapy strategies, including botulinum toxin, prophylactic, and acute treatments. Participants will also document migraine attacks, triggers, and symptoms through a digital migraine diary app. By combining continuous smartwatch data, the migraine diary and the implementation of questionnaires, the study seeks to provide a comprehensive understanding of how migraines and their treatments impact daily life and patient outcomes.

Detailed description: Migraine is one of the most prevalent neurological disorders globally, significantly affecting patients' quality of life. However, due to the complexity of monitoring triggers and symptoms, determining the most effective individualized treatment regimen can be difficult. In this observational study a total of 55 patients with episodic or chronic migraines have been observed over a six-month period, with continuous data collection from both smartwatch and migraine diary app. Clinical health questionnaires were completed at baseline (V1), 3 months (V2), and 6 months (V3), assessing the impact of migraine attacks on daily functioning. The data gathered from the smartwatch (Withings ScanWatch) includes activity-related metrics (step count, minutes of activity at various intensity levels), basic cardiovascular measurements (heart rate), and sleep data (total sleep duration, sleep quality, etc.). Additionally, the Migraine App allows patients to document the precise timing of migraine attacks, associated symptoms, potential triggers, and the medications taken, including their effectiveness. The MIRA study aims to explore the potential of wearable devices and digital health tools to systematically identify migraine triggers and physiological responses through continuous monitoring. By integrating both clinical assessments and digital data, this study seeks to provide a comprehensive, longitudinal understanding of migraine dynamics and their impact on daily life.

Eligibility criteria: Inclusion Criteria:

Patients must meet the following criteria to be eligible to participate in the study:

* ≥ 18 years of age
* Diagnosed migraine syndrome
* Possession and ability to use a smartphone (Android 8.1 or later, or iOS 12.3 or later)

Exclusion Criteria:

* Missing informed consent
* Unwillingness or inability to use the smartphone app
* Comorbidity leading to impaired comprehension or successful completion of the study, such as (but not limited to) psychiatric comorbidities or dementia. The decision will be at the discretion of the investigators.

Primary outcomes:
measure: End-of-dose phenomena (EoD) in botulinum toxin therapy
timeFrame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Quality of life (QoL)
timeFrame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Migraine Disability (MIDAS)
timeFrame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in fatigue severity (BFI)
timeFrame: Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Change in Depressive symptoms (BDI-FAST)
timeFrame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
measure: Smartwatch usage
timeFrame: After 6 months (V3)
measure: Migraine Triggers
timeFrame: 180 days
measure: Medication taken during migraine attacks
timeFrame: 180 days
measure: Duration of migraine attacks
timeFrame: 180 days
measure: Pain level and localization of headache
timeFrame: 180 days
measure: Wearing time of smartwatch (daily)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: step count
timeFrame: 180 days
measure: Longitudinal development of activity parameter: approximate distance traveled (meter)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of soft activity (seconds) defined by Withings Description: Examples for soft activity: Sleeping, Sitting quietly, Walking slowly, Typing on a computer keyboard while seated, Watching televisio
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of moderate activity (seconds) defined by Withings Description: Examples for moderate activity: Walking fast, Cleaning (vacuuming, washing windows, etc.), Playing doubles tennis or badminton, T
timeFrame: 180 days
measure: Longitudinal development of activity parameter: duration of intense activity (seconds) defined by Withings Description: Examples for intense activity: Hiking, Running, Carrying heavy loads, Riding a bike, Playing football, baseball, or tennis (singles),
timeFrame: 180 days
measure: Longitudinal development of activity parameter: sum of all active time (seconds)
timeFrame: 180 days
measure: Longitudinal development of activity parameter: approximate calories burned Time
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time awake (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: number of times user woke up
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time to sleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: total time in bed (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: total time asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: ratio of sleep/time in bed
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
timeFrame: 180 days
measure: Longitudinal development of sleep parameter: Withings Sleep score Description: Defined by Withings as follows: It measures every night's sleep and provides a score out of 100 points based on 4 key inputs: - Duration (total time spent sleeping) - Depth (p
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: average heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: maximal heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: minimum heartrate
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in light heartrate zone (seconds) Description: Light heartrate zone is defined by Withings as follows: from 0% inclusive to 50% exclusive of maximum heart rate.
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in moderate heartrate zone (seconds) Description: Moderate heartrate zone is defined by Withings as follows: from 50% included to 70% excluded of maximal heart rate.
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in intense heartrate zone (seconds) Description: Intense heartrate zone is defined by Withings as follows: from 70% included to 90% excluded of maximal heart rate.
timeFrame: 180 days
measure: Longitudinal development of cardiovascular parameter: time in maximal heartrate zone (seconds) Description: Maximal heartrate zone is defined by Withings as follows: from 90% included to 100% included of maximal heart rate
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Medical Faculty, Heinrich-Heine-University
state: Northrhine-Westphalia
Study officials:
References: