Sleep, Stress and Migraine — Personalized Sleep and Stress Training

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

MiSleepS combines continuous physiological data from a WHOOP wrist wearable with brief ecological momentary assessments delivered by a smartphone app to map how sleep, circadian patterns, and stress relate to migraine attacks. Participants wear the device and report daily sleep, stress, and headache information for an observational period, after which they receive individualized, non-pharmacological recommendations for sleep hygiene and stress management. The intervention is profile-based behavioral training aimed at changing routines rather than adding medication. The study is monocentric and conducted at the University Hospital Zurich with adult patients who meet ICHD-3 criteria for episodic migraine.

Why it matters

Who can join: the full rules

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)
* Concomitant steroid medication (self-reported)
* Known or suspected alcohol, drug or medication abuse (i.e. \> 0.5 l wine or 1 l beer per day)
* Inability to follow the procedures of the study (e.g., due to language problems, cognitive deficits, instable home situation)
* Concurrent participation in another study involving drug and behavioral interventions within 3 months prior to and during the present study, as well as participation in an ongoing study with data collection through SEMA3
* Planned medical intervention of substantial relevance requiring hospitalization for more than 24 hours (e.g. surgery) during intervention (routine assessments, e.g. check-ups will be allowed)
* Shift work with working during the night
* Travelling more than 2 time zones in the last month before the observation or intervention periods or during the study
* Persons who are pregnant or breastfeeding

Where it's running

• University Hospital Zurich, Department of Neurology
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Susanne Wegener — University Hospital Zurich, Department of Neurology
• Study coordinator: Susanne Wegener
• Email: susanne.wegener@usz.ch
• Phone: +41 44 255 55 11

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.