Sleep, Stress and Migraine - an Observational and Training Study (NCT07573488) | Clinical Trial Compass
RecruitingNot Applicable
Sleep, Stress and Migraine - an Observational and Training Study
Switzerland80 participantsStarted 2026-05-18
Plain-language summary
The MiSleepS study investigates how sleep disturbances and stress are linked to migraine attacks. Participants wear a device called a WHOOP band, which tracks sleep and body signals, and answer brief daily questions via a smartphone app about their sleep, stress levels, and migraine symptoms. The goal is to identify personal patterns that may contribute to migraine. Based on these insights, participants receive individualized recommendations to improve their sleep and daily routines - aiming to reduce migraine attacks in the long term without medication. The study is conducted at the University Hospital Zurich and is aimed at adults with episodic migraine.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged between 18 and 65 years
* Diagnosis of episodic migraine according to The International Classification of Headache Disorders (ICHD-3) criteria confirmed by our headache specialists
* 4 to 14 headache days per month (mean value based on the 3 months prior to study enrollment)
* Ability to give informed consent and to adhere to the study protocol
* Sufficient German language comprehension to follow the study procedures and answer all questions related to the study outcomes
* Stable migraine medication regimen for the past 3 months and throughout the study period
Exclusion Criteria:
* Diagnosis of sleep disorders that could interfere with the sleep intervention, such as obstructive sleep apnea with an apnea-hypopnea index (AHI) \> 15, Restless Legs Syndrome, frequent (i.e. weekly) Non-rapid eye movement (NREM) sleep parasomnia, REM Behavior Disorder (RBD)
* Current diagnosis of a psychiatric disorder that is inadequately treated or therapy-resistant and may interfere with study participation or adherence to study procedures (this includes, but is not limited to: schizophrenia, schizoaffective disorder, bipolar disorder (type I), post-traumatic stress disorder with active symptoms, or major depressive disorder with ongoing functional impairment despite treatment). Diagnosis must be confirmed by clinical history or treating physician.
* Regular use of benzodiazepines and other central nervous system (CNS)-depressant substances (self-reported)
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decrease in the number of migraine days (6 weeks)
Timeframe: From phase A (baseline) to the end of phase B (6 weeks of intervention).