An interventional study of Profile-based behavioral sleep and stress management in Migraine, Sleep Disorder (Disorder) and Stress, sponsored by Susanne Wegener. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by Susanne Wegener · Not applicable, Interventional, and Other
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.
Migraine is a widespread neurological disorder affecting more than one billion people worldwide, and is among the leading causes of disability, particularly in women. It is characterized by episodic or chronic headaches and often accompanied by nausea, photophobia, and cognitive impairment. Despite advances in pharmacological therapies - such as the advent of CGRP antagonists - a large proportion of patients remain undertreated or refractory to standard interventions. Critically, migraine is influenced by multiple behavioral and environmental triggers, among which sleep disturbances and stress are consistently among the most frequently reported and most modifiable. However, their complex and often bidirectional interactions with migraine are still not fully understood, and most available research is limited by methodological constraints, including short observation periods, retrospective data, and insufficient attention to sex and gender variables.
The Migraine Sleep Study (MiSleepS) is a prospective, two-phase clinical study aiming to investigate the role of sleep, circadian rhythm, and stress as dynamic triggers of migraine and to evaluate the effectiveness of individualized, non-pharmacological behavioral interventions. Conducted at the University Hospital Zurich, this monocentric study will combine high-resolution physiological data captured via the WHOOP 5.0 wrist-worn wearable device with real-time, ecological momentary assessments (EMA) collected through the SEMA3 smartphone app. These dual digital tools enable continuous monitoring of key variables such as sleep duration, sleep architecture, heart rate variability, perceived stress, and migraine occurrence and severity.
Participants will undergo a five-week observational phase (phase A), during which their natural sleep-stress-migraine interactions will be captured without interference. An interim analysis will be conducted to identify individual behavioral and circadian profiles, including insomnia-like patterns, sleep deprivation, social jetlag, and chronotype mismatch. Based on these results, participants will be stratified into clusters and assigned a tailored behavioral plan to address their specific profile. In the subsequent six-week intervention phase (phase B), participants will implement these behavioral strategies, supported by remote follow-ups and daily app-based tracking. The primary endpoint will be the change in monthly migraine days, while secondary endpoints include migraine severity, sleep quality, stress levels, and adherence to recommendations.
To control for observation-related confounding - such as the Hawthorne effect - a run-in cohort of the first ten participants will follow a modified protocol. While they undergo the same assessment and tracking procedures, they will not receive any behavioral recommendations in phase B. This approach allows for differentiation between improvements due to heightened self-awareness and those attributable to the targeted intervention itself.
The study further aims to examine sex- and gender-related differences in migraine pathophysiology and response to behavioral interventions, using validated tools such as the Stanford Gender-Related Variables for Health Research (GVHR) score (Nielsen et al., 2021). By integrating physiological, psychological, and gender-related dimensions, MiSleepS aspires to develop a more individualized understanding of migraine and to explore scalable, low-risk, non-pharmacological treatment strategies that can be implemented in clinical practice.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Susanne Wegener as lead sponsor.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Profile-based behavioral sleep and stress management
After 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.
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).
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).
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).
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).
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).
Association between perceived stress and migraine onset
Correlation between perceived stress measured daily using the Stress Numeric Rating Scale-11 (Stress NRS-11) and the occurrence of migraine onset (yes/no).
Time frame: Phase A (5 weeks).
Difference in total sleep duration between nights with and without migraine attacks
Mean difference in total sleep duration (hours), derived from wearable device data and daily entries, comparing nights with reported migraine attacks (yes) versus nights without migraine attacks (no), as recorded in the SEMA3 app.
Time frame: Phase A (5 weeks)
Difference in sleep quality between nights with and without migraine attacks
Mean difference in subjective sleep quality, assessed via daily entries, comparing nights with reported migraine attacks (yes) versus nights without migraine attacks (no).
Time frame: Phase A (5 weeks)
Difference in light, deep, and REM-sleep proportion between nights with and without migraine attacks
Mean difference in the proportion of time spent in light sleep, deep sleep, and REM-Sleep (% per night), derived from wearable device data, comparing nights with reported migraine attacks (yes) versus nights without migraine attacks (no).
Time frame: Phase A (5 weeks)
Change in subjective sleep quality from baseline to end of intervention
Mean change in subjective sleep quality measured using a validated questionnaire (Pittsburgh Sleep Quality Index, PSQI) and daily entries in the SEMA3 app, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B).
Time frame: From phase A (baseline) to the end of phase B (intervention, 6 weeks).
Change in total sleep duration from baseline to end of intervention
Mean change in total sleep duration (hours per night), derived from wearable device data, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B).
Time frame: From phase A (baseline) to the end of phase B (intervention, 6 weeks).
Change in sleep consistency score from baseline to end of intervention
Mean change in sleep consistency score, derived from wearable device data, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B).
Time frame: From phase A (baseline) to the end of phase B (intervention, 6 weeks).
Change in sleep onset variability from baseline to end of intervention
Mean change in variability of sleep onset timing, derived from wearable device data, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B).
Time frame: From phase A (baseline) to the end of phase B (intervention, 6 weeks).
Change in perceived stress from baseline to end of intervention
Mean change in perceived stress measured daily using the Stress Numeric Rating Scale-11 (0-10) via the SEMA3 app, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B).
Time frame: From phase A (baseline) to the end of phase B (intervention, 6 weeks).
Decrease in the number of migraine days (3 months)
Change in the number of migraine days per month from phase A (baseline) to the end of the study (3 months) (outcome measures: 30% reduction in the number of self-reported monthly migraine days before vs. after the intervention)
Time frame: From phase A (baseline) to the end of the study (3 months)
Change in migraine severity from baseline to end of intervention
Mean change in migraine severity, measured as average daily Numeric Rating Scale (NRS; 0-10) scores recorded in the SEMA3 app, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B). Analysis includes only participants reporting migraine episodes in both phases.
Time frame: From phase A (baseline) to the end of phase B (intervention phase)
Change in migraine attack duration from baseline to end of intervention
Mean change in migraine attack duration, measured as mean hours per episode based on participant self-report in the SEMA3 app, comparing the observational phase (Phase A, baseline) to the end of the intervention phase (Phase B). Analysis includes only participants reporting migraine episodes in both phases.
Time frame: From phase A (baseline) to the end of phase B (intervention phase)
Change in migraine severity from baseline to 3-month follow-up
Mean change in migraine severity, measured as average daily Numeric Rating Scale (NRS; 0-10) scores recorded in the SEMA3 app, comparing the observational phase (Phase A, baseline) to the end of the study (3-month follow-up). Analysis includes only participants reporting migraine episodes in both periods.
Time frame: From phase A (baseline) to 3-month follow-up
Change in migraine attack duration from baseline to 3-month follow-up
Mean change in migraine attack duration, measured as mean hours per episode based on participant self-report in the SEMA3 app, comparing the observational phase (Phase A, baseline) to the end of the study (3-month follow-up). Analysis includes only participants reporting migraine episodes in both periods.
Time frame: From phase A (baseline) to 3-month follow-up
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)
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).
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)
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 B
Adherence rate to behavioral intervention recommendations
Adherence to prescribed behavioral recommendations, measured as the percentage of completed adherence logs relative to expected entries over the intervention period.
Time frame: Phase B (intervention phase) through 3-month follow-up
Participant-reported feasibility, usefulness, and perceived benefit of the intervention
Assessment of participant-reported feasibility, usefulness, and perceived benefit of the behavioral intervention, measured using a standardized user feedback questionnaire and summarized using descriptive statistics and thematic analysis of qualitative responses.
Time frame: End of Phase B (intervention phase) and 3-month follow-up
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for May 2026; primary completion for Apr 2027, 11 months later.
Of 309 non-industry interventional studies with no phase under Migraine Disorders, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 358 studies reached it within 15 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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