Migraine Research with Smartwatch Application

NCT06862544 | Active Not Recruiting

• 1 other identifier: MIRA_1.0
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Keywords

Migraine; Headache; Smartwatch; Wearables; Digital health tools

Outcome Measures

Primary Outcomes (35)

• 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: 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: 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: 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: 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: 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: 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.

  After 6 months (V3)

• Migraine Triggers

  Migraine Triggers through migraine diary

  180 days

• Medication taken during migraine attacks

  Medication taken during migraine attacks through migraine diary

  180 days

• Duration of migraine attacks

  Duration of migraine attacks through migraine diary

  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.

  180 days

• Wearing time of smartwatch (daily)

  180 days

• Longitudinal development of activity parameter: step count

  180 days

• Longitudinal development of activity parameter: approximate distance traveled (meter)

  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

  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

  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),

  180 days

• Longitudinal development of activity parameter: sum of all active time (seconds)

  180 days

• Longitudinal development of activity parameter: approximate calories burned Time

  180 days

• Longitudinal development of sleep parameter: time awake (seconds)

  180 days

• Longitudinal development of sleep parameter: number of times user woke up

  180 days

• Longitudinal development of sleep parameter: time to sleep (seconds)

  180 days

• Longitudinal development of sleep parameter: total time in bed (seconds)

  180 days

• Longitudinal development of sleep parameter: total time asleep (seconds)

  180 days

• Longitudinal development of sleep parameter: ratio of sleep/time in bed

  180 days

• Longitudinal development of sleep parameter: time spent in bed before falling asleep (seconds)

  180 days

• Longitudinal development of sleep parameter: time awake after first falling asleep (seconds)

  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

  180 days

• Longitudinal development of cardiovascular parameter: average heartrate

  180 days

• Longitudinal development of cardiovascular parameter: maximal heartrate

  180 days

• Longitudinal development of cardiovascular parameter: minimum heartrate

  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.

  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.

  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.

  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

  180 days

Study Arms (1)

Migraine patients

Patients with episodic or chronic migraine

Device: Smartwatch (Withings Scanwatch 2)

Interventions

Smartwatch (Withings Scanwatch 2) DEVICE

All-day monitoring of patients via smartwatch and migraine diary app

Migraine patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with episodic or chronic migraine 18 years or older

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

Medical Faculty, Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: May 17, 2024
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)