Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07573488

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Observational Phase

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

Intervention Phase

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

Loading map...

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

Similar Trials

A Comparison of Biodegradable and Metal Occluders in Patient...

PFO - Patent Foramen Ovale

Actively Recruiting

2 locations

A Feasibility Trial of Eye Movement Desensitization and Repr...

Post Traumatic Stress Symptoms

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here