Sleep, Stress and Migraine - an Observational and Training Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSusanne Wegener
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Profile-based behavioral sleep and stress management
BehavioralAfter completion of the 5-week observational phase (phase A), the study team will conduct an interim analysis integrating WHOOP biometric data and SEMA3 self-reports on migraine, sleep, and stress. The aim is to identify individual sleep-stress patterns linked to migraine activity. Based on predefined criteria, participants will be assigned to one of four behavioral profiles: insomnia-like, sleep deprivation, social jetlag, or circadian misalignment. Mixed or unclassified cases will be grouped separately. All participants receive general behavioral recommendations on sleep hygiene, scheduling, and stress management. WHOOP-based personalized tips (e.g., optimal sleep windows, recovery days) will be encouraged. Profile-based participants also receive targeted prioritization of interventions most relevant to their sleep-migraine pattern, including techniques such as rhythm stabilization, relaxation training, or strategic light exposure.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Personalized Behavioral Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Decrease in the number of migraine days (6 weeks)
The primary endpoint is the change in the number of migraine days per month from phase A (baseline) to the end of phase B, following 6 weeks of intervention. A reduction of 30% in self-reported monthly migraine days is defined as the primary outcome measure.
Time frame
From phase A (baseline) to the end of phase B (6 weeks of intervention).Secondary outcomes
1
Association between total sleep time and migraine onset
Correlation between objectively measured total sleep time (hours, derived from wearable device data) and the occurrence of migraine onset (yes/no), assessed using daily entries.
Time frame
Phase A (5 weeks).2
Association between sleep latency and migraine onset
Correlation between sleep latency (minutes, derived from wearable device data) and the occurrence of migraine onset (yes/no), assessed using daily entries.
Time frame
Phase A (5 weeks).3
Association between sleep-wake time variability and migraine onset
Correlation between variability in sleep-wake timing (derived descriptively from wearable device data) and the occurrence of migraine onset (yes/no), assessed using daily entries.
Time frame
Phase A (5 weeks).4
Association between recovery score and migraine onset
Correlation between recovery scores (as calculated by the wearable device application) and the occurrence of migraine onset (yes/no), assessed using daily entries.
Time frame
Phase A (5 weeks).Other outcomes
1
Identification of participant subgroups based on baseline sleep, stress, and migraine characteristics
Identification of distinct participant subgroups using multivariate statistical techniques (e.g., cluster analysis, latent class modeling) based on baseline profiles including wearable-derived sleep metrics, daily perceived stress, and migraine frequency and severity.
Time frame
Baseline (ende of Phase A)2
Association between baseline subgroup classification and intervention response
Association between participant subgroup membership (derived from baseline sleep, stress, and migraine profiles) and response to the behavioral intervention, defined as change in monthly migraine days and responder status (≥30% reduction).
Time frame
From phase A (baseline) to the end of the study (3-month follow-up).3
Sex and gender differences in sleep-stress-migraine associations
To assess whether sex (biological) and gender (psychosocial) influence the association between sleep, circadian rhythm variables, perceived stress, and migraine burden (phase A). Sex will be recorded as a binary variable (male/female). Gender will be assess using The Stanford Gender-Related Variables for Health Research (GVHR), which reflects psychosocial gender traits (e.g., role orientation, identity, stress coping) and allows continuous, multidimensional assessment beyond binary sex. Outcome measures: * Subgroup comparisons of correlations between: wearable-derived sleep and recovery data (e.g. total sleep time, variability, heart rate variability (HRV)), daily perceived stress (Stress NRS-11), migraine symptoms (from SEMA3 data: frequency, intensity, NRS, duration in hours). * Moderation analyses using GVHR (Measurement tools: WHOOP biometric data, migraine symptom logs (SEMA3), GVHR, Stress NRS-11)
Time frame
Phase A (5 weeks)4
Sex and gender differences in response to the personalized behavioral intervention
To evaluate whether sex and gender influence the effectiveness of the personalized behavioral intervention delivered in Phase B. Effectiveness is defined by change in migraine frequency, severity, and stress levels from Phase A to Phase B. Outcome measures: * Sex- and gender-based subgroup analyses of: change in monthly migraine days, change in the migraine severity (NRS) and duration (hours), and change in perceived stress (Stress NRS-11, PSS-10). * Interaction effects (sex x intervention; gender score (GVHR x intervention). (Measurement tools: WHOOP biometric data, migraine symptom logs (SEMA3), GVHR, Stress NRS-11, PSS-10)
Time frame
Pre-post comparison: phase A vs. phase BSponsors and contacts
Click on the lead sponsor to view all of their trials.
Susanne Wegener
Lead sponsor
University of Zurich
Sponsor institution
Source ClinicalTrials.gov