Actively Recruiting
Migraine Sleep Study (MiSleepS) Investigating Sleep and Stress as Triggers in Episodic Migraine with Personalized Behavioral Interventions
Led by Susanne Wegener · Updated on 2026-05-07
80
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how sleep disturbances and stress are linked to migraine attacks in adults with episodic migraine. This study aims to identify personal patterns that may trigger migraines by continuously monitoring sleep and body signals using a WHOOP wearable device, alongside daily smartphone app questions about sleep, stress, and migraine symptoms. The research also explores sex- and gender-related differences in migraine and response to behavioral changes, aiming to develop individualized, non-drug strategies to help reduce migraine attacks over time. Participants will first undergo a five-week observational phase where their natural sleep, stress, and migraine interactions are tracked without any intervention. After analyzing this data, participants are grouped based on their sleep-stress profiles and receive tailored behavioral recommendations targeting their specific patterns during a six-week intervention phase. A small control group follows the same monitoring but does not receive personalized advice to help separate effects of increased self-awareness from the intervention. Throughout the study, participants will wear the WHOOP device and use the app daily to report symptoms and behaviors. Researchers will measure changes in migraine days, migraine severity, sleep quality, stress levels, and adherence to recommendations. The study includes remote follow-ups and lasts about 11 weeks in total, with additional assessment of long-term migraine changes at three months. Safety and progress are closely monitored without medication changes during the study period.
CONDITIONS
Brief Title
Sleep, Stress and Migraine - an Observational and Training Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 65 years
- Diagnosis of episodic migraine confirmed by headache specialists according to ICHD-3 criteria
- Experiencing 4 to 14 headache days per month based on the 3 months before enrollment
- Able to provide informed consent and follow the study protocol
- Sufficient German language skills to complete study procedures and questionnaires
- Stable migraine medication for at least 3 months before and during the study
You will not qualify if you...
- Diagnosed sleep disorders interfering with the study, such as obstructive sleep apnea with AHI > 15, restless legs syndrome, frequent non-REM sleep parasomnia, or REM behavior disorder
- Untreated or therapy-resistant psychiatric disorders that may affect participation, including schizophrenia, schizoaffective disorder, bipolar I, active PTSD, or major depression with ongoing impairment
- Regular use of benzodiazepines or other central nervous system depressants
- Use of steroid medications
- Known or suspected alcohol or drug abuse exceeding specified limits
- Inability to follow study procedures due to language, cognitive, or unstable home conditions
- Participation in another drug or behavioral intervention study or ongoing SEMA3 data collection study within 3 months before or during this study
- Planned major medical interventions requiring hospitalization over 24 hours during the study
- Shift work involving night shifts
- Travel across more than 2 time zones within one month before or during the study
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 5 weeks
Participants are monitored with continuous wearable tracking and daily app-based self-reporting to capture natural sleep, stress, and migraine patterns without intervention.
Continuous monitoring using wearable device and daily app self-reports
Duration - 6 weeks
Based on the observational data, participants receive personalized behavioral recommendations tailored to their sleep and stress profiles and implement these strategies with ongoing digital monitoring.
Daily app-based tracking and remote follow-up support
Trial Site Locations
Total: 1 location
1
University Hospital Zurich, Department of Neurology
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
S
Susanne Wegener
M
Marie Therese Kleinsorge
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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