Migraine Research with Smartwatch Application

NCT ID: NCT06862544

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-17
• Study Completion Date: 2025-03-07

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.

Conditions

Migraine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Migraine patients

Patients with episodic or chronic migraine

Smartwatch (Withings Scanwatch 2)

Intervention Type: DEVICE

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

Interventions

Smartwatch (Withings Scanwatch 2)

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Faculty, Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

MIRA_1.0

Identifier Type: -

Identifier Source: org_study_id