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.
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.
Study Type
OBSERVATIONAL
Enrollment
55
All-day monitoring of patients via smartwatch and migraine diary app
Medical Faculty, Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, Germany
End-of-dose phenomena (EoD) in botulinum toxin therapy
The End-of-dose-phenomena-Questionnaire assesses the effectiveness of a treatment at the end of its dosing interval and asks about an increase in symptoms. Before their next botulinum toxin treatment, patients can state whether they have experienced a worsening of symptoms in recent weeks and, if so, for how many days and which migraine symptoms have worsened.
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Quality of life (QoL)
WHOQoL-BREF (World Health Organization Quality of Life Questionnaire Brief Version) is an instrument for measuring patients' subjective quality of life in a wide range of specific areas including Physical health, Psychological well-being, Social relationships and Environment. The WHOQoL-BREF uses a score range of 4 to 20 for each domain in its raw form. These raw scores are then converted to a 0-100 scale, where higher scores indicate better quality of life and lower scores indicate poorer quality of life.
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Migraine Disability (MIDAS)
MIDAS (Migraine Disability Assessment) is a standardized tool used to assess the impact of migraine on various aspects of life, including work, school, social activities, and leisure activities. It is calculated based on the number of days affected by migraines in the past three months with higher scores indicating greater disability and a more severe impact on daily activities. Lower scores suggest less disruption from migraines.
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Pittsburgh Sleep Quality Index (PSQI)
The Change in Pittsburgh Sleep Quality Index (PSQI) is a tool to assess the quality of sleep over the past month. The score range for the PSQI is from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in fatigue severity (BFI)
Brief Fatigue Inventory (BFI) is a questionnaire to assess fatigue severity. The BFI consists of 9 questions, each answered on an 11-point scale. The total score on the BFI ranges from 0 to 10, where 0 represents no fatigue and 10 represents the worst possible fatigue. In general, higher scores indicate greater severity of fatigue, and lower scores suggest less severe or no fatigue.
Time frame: Time frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Change in Depressive symptoms (BDI-FAST)
Beck Depression Inventory (BDI) FAST is a questionnaire to screen for depression in migraine patients. It is a shortened version of the full Beck Depression Inventory (BDI) and contains 7 items. Each item is scored on a 4-point scale (0 to 3), with a higher score indicating more severe depressive symptoms.
Time frame: Time Frame: Screening + Baseline (V1), After 3 months (V2), After 6 months (V3)
Smartwatch usage
Questionnaire about smartwatch usage. Patients are presented with 17 statements about the smartwatches, focusing on practicality, usability, and everyday suitability. They can score each statement from 1 to 5, where 5 means strong agreement and 1 means strong disagreement.
Time frame: After 6 months (V3)
Migraine Triggers
Migraine Triggers through migraine diary
Time frame: 180 days
Medication taken during migraine attacks
Medication taken during migraine attacks through migraine diary
Time frame: 180 days
Duration of migraine attacks
Duration of migraine attacks through migraine diary
Time frame: 180 days
Pain level and localization of headache
Pain level and localization of headache through migraine diary. For each migraine attack there is a Numerical Rating Scale (NRS) - a simple method for pain assessment, where patients rate their pain on a scale from 0 to 10. In the migraine app, patients can specify the exact location of their headache. A front view of the head with 12 sections and a back view with 6 sections are presented. Patients can select multiple sections to visually pinpoint the headache location.
Time frame: 180 days
Wearing time of smartwatch (daily)
Time frame: 180 days
Longitudinal development of activity parameter: step count
Time frame: 180 days
Longitudinal development of activity parameter: approximate distance traveled (meter)
Time frame: 180 days
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
Time frame: 180 days
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
Time frame: 180 days
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),
Time frame: 180 days
Longitudinal development of activity parameter: sum of all active time (seconds)
Time frame: 180 days
Longitudinal development of activity parameter: approximate calories burned Time
Time frame: 180 days
Longitudinal development of sleep parameter: time awake (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: number of times user woke up
Time frame: 180 days
Longitudinal development of sleep parameter: time to sleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time in bed (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: total time asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: ratio of sleep/time in bed
Time frame: 180 days
Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)
Time frame: 180 days
Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)
Time frame: 180 days
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
Time frame: 180 days
Longitudinal development of cardiovascular parameter: average heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: maximal heartrate
Time frame: 180 days
Longitudinal development of cardiovascular parameter: minimum heartrate
Time frame: 180 days
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.
Time frame: 180 days
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.
Time frame: 180 days
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.
Time frame: 180 days
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
Time frame: 180 days
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