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Migraine Sleep Study (MiSleepS) - The Role of Sleep and Stress as a Trigger in Migraine

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
University Hospital Zurich, Department of Neurology
RECRUITING
Zurich
Contact Information
Primary
Susanne Wegener
susanne.wegener@usz.ch
+41 44 255 55 11
Backup
Marie Therese Kleinsorge
marie.kleinsorge@usz.ch
+41 44 255 55 11
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 80
Treatments
Experimental: Personalized Behavioral Intervention Arm
N=70 participants undergo a 5-week observational phase (phase A) with continuous wearable tracking and daily app-based self-reporting. After an interim analysis, they are assigned to a sleep/stress-related behavioral profiles. In the following 6-week intervention phase (phase B), they receive personalized behavioral recommendations tailored to their profile and implement them with ongoing digital monitoring.~The first 10 participants (run-in group) follow the same protocol but do not receive personalized interventions in phase B. This group serves as a control to distinguish behavioral effects of the intervention from those caused by increased self-monitoring or study participation alone (Hawthorne effect).
Related Therapeutic Areas
Sponsors
Leads: Susanne Wegener

This content was sourced from clinicaltrials.gov