Sleep, Stress and Migraine - an Observational and Training Study
Recruiting · NCT07573488 · Interventional (participants receive a specific treatment) · Lead sponsor: Susanne Wegener
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
1 location listed.
- University Hospital Zurich, Department of Neurology - Zurich, Switzerland