MigraineMiSleepSNCT07573488
Sleep, Stress and Migraine - an Observational and Training Study
A study testing Profile-based behavioral sleep and stress management in people with Migraine and Sleep Disorder (Disorder), run by Susanne Wegener at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine, Sleep Disorder (Disorder), Stress
- What is being tested?
- Profile-based behavioral sleep and stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 May 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Department of Neurology
Zurich, 8091
Susanne Wegener, +41 44 255 55 11, susanne.wegener@usz.ch
Marie Therese Kleinsorge, +41 44 255 55 11, marie.kleinsorge@usz.ch
About this study
Official title: Migraine Sleep Study (MiSleepS) - The Role of Sleep and Stress as a Trigger in Migraine
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.
Read the detailed description
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.
- Conditions
- Migraine, Sleep Disorder (Disorder), Stress, Migraine in Adults
- Being tested
- Profile-based behavioral sleep and stress management
- Keywords
- migraine, behavioral therapy, sleep hygiene, stress management, migraine triggers, non-medical prophylaxis
- Medical subject headings
- Migraine Disorders, Sleep Wake Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profile-based behavioral sleep and stress managementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Behavioral Intervention Arm | Experimental | 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). Receives: Behavioral: Profile-based behavioral sleep and stress management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From phase A (baseline) to the end of phase B (6 weeks of intervention).
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From phase A (baseline) to 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start18 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MiSleepS is a monocentric, prospective clinical trial with a single-group, within-subject design. All participants follow the same protocol: a 5-week observational phase (Phase A), followed by a 6-week interventional phase (Phase B). After interim analysis, participants receive personalized behavioral recommendations based on their individual sleep-stress-migraine profile. The first 10 participants (run-in cohort) undergo the same assessments but do not receive an intervention in Phase B. This subgroup serves to control for observational bias (Hawthorne effect) but is not considered a separate study arm. No randomization or parallel group assignment is applied. The study evaluates within-subject changes in migraine burden before and after the tailored intervention, consistent with a single-group interventional model.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Susanne Wegener
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Susanne Wegener, University of Zurich
- Investigators
- Susanne Wegener, Principal investigator, University Hospital Zurich, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573488
- Sponsor's protocol ID
- 2025-01186
- Other IDs
- 2025
- Acronym
- MiSleepS
- Status last verified
- Jul 2025
- First submitted
- 7 Jun 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Migraine Sleep Study (MiSleepS) - The Role of Sleep and Stress as a Trigger in Migraine
- ClinicalTrials.gov ID
- NCT07573488
- Acronym / sponsor ID
- MiSleepS / 2025-01186
- Conditions
- Migraine, Sleep Disorder (Disorder), Stress, Migraine in Adults
- Keywords
- migraine, behavioral therapy, sleep hygiene, stress management, migraine triggers, non-medical prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Susanne WegenerUniversity, hospital or other
- Study start
- 18 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MiSleepS is a monocentric, prospective clinical trial with a single-group, within-subject design. All participants follow the same protocol: a 5-week observational phase (Phase A), followed by a 6-week interventional phase (Phase B). After interim analysis, participants receive personalized behavioral recommendations based on their individual sleep-stress-migraine profile. The first 10 participants (run-in cohort) undergo the same assessments but do not receive an intervention in Phase B. This subgroup serves to control for observational bias (Hawthorne effect) but is not considered a separate study arm. No randomization or parallel group assignment is applied. The study evaluates within-subject changes in migraine burden before and after the tailored intervention, consistent with a single-group interventional model.
| Arm | Type | Receives |
|---|---|---|
| Personalized Behavioral Intervention Arm | Experimental | Behavioral: Profile-based behavioral sleep and stress managementN=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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profile-based behavioral sleep and stress managementAfter 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. | Behavioural | Personalized Behavioral Intervention Arm |
Primary outcome
Decrease in the number of migraine days (6 weeks)
Time frame: From phase A (baseline) to the end of phase B (6 weeks of intervention).
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.
18 secondary outcomes
Association between total sleep time and migraine onset
Time frame: Phase A (5 weeks).
Association between sleep latency and migraine onset
Time frame: Phase A (5 weeks).
Association between sleep-wake time variability and migraine onset
Time frame: Phase A (5 weeks).
Association between recovery score and migraine onset
Time frame: Phase A (5 weeks).
Association between perceived stress and migraine onset
Time frame: Phase A (5 weeks).
Difference in total sleep duration between nights with and without migraine attacks
Time frame: Phase A (5 weeks)
Difference in sleep quality between nights with and without migraine attacks
Time frame: Phase A (5 weeks)
Difference in light, deep, and REM-sleep proportion between nights with and without migraine attacks
Time frame: Phase A (5 weeks)
Change in subjective sleep quality from baseline to end of intervention
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
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
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
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
Time frame: From phase A (baseline) to the end of phase B (intervention, 6 weeks).
Decrease in the number of migraine days (3 months)
Time frame: From phase A (baseline) to the end of the study (3 months)
Change in migraine severity from baseline to end of intervention
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
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
Time frame: From phase A (baseline) to 3-month follow-up
Change in migraine attack duration from baseline to 3-month follow-up
Time frame: From phase A (baseline) to 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susanne Wegener principal investigator
University Hospital Zurich, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profile-based behavioral sleep and stress management in people with Migraine and Sleep Disorder (Disorder), run by Susanne Wegener at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susanne Wegener (+41 44 255 55 11, susanne.wegener@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in the number of migraine days (6 weeks) (time frame: From phase A (baseline) to the end of phase B (6 weeks of intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.