Sleep, Stress and Migraine - an Observational and Training Study

NCT07573488 | Recruiting

• 1 other identifier: 2025-01186
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine; Sleep Disorder (Disorder); Stress; Migraine in Adults

Keywords

migraine; behavioral therapy; sleep hygiene; stress management; migraine triggers; non-medical prophylaxis

Outcome Measures

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.

  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

  Phase A (5 weeks).

• Association between sleep latency and migraine onset

  Phase A (5 weeks).

• Association between sleep-wake time variability and migraine onset

  Phase A (5 weeks).

• Association between recovery score and migraine onset

  Phase A (5 weeks).

• Association between perceived stress and migraine onset

  Phase A (5 weeks).

Other Outcomes (6)

• Identification of participant subgroups based on baseline sleep, stress, and migraine characteristics

  Baseline (ende of Phase A)

• Association between baseline subgroup classification and intervention response

  From phase A (baseline) to the end of the study (3-month follow-up).

• Sex and gender differences in sleep-stress-migraine associations

  Phase A (5 weeks)

Study Arms (1)

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).

Behavioral: Profile-based behavioral sleep and stress management

Interventions

Profile-based behavioral sleep and stress management BEHAVIORAL

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.

Personalized Behavioral Intervention Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Susanne Wegener: lead

Study Sites (1)

University Hospital Zurich, Department of Neurology

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Sleep Wake Disorders; Sleep Hygiene

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Health Behavior; Behavior

Study Officials

• Susanne Wegener

  University Hospital Zurich, Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Wegener

CONTACT

+41 44 255 55 11; susanne.wegener@usz.ch

Marie Therese Kleinsorge

CONTACT

+41 44 255 55 11; marie.kleinsorge@usz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: 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.

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: May 7, 2026
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2025-07

Locations

CH (1)