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New treatment option for Migraine
Official title Sleep, Stress and Migraine - an Observational and Training Study
ClinicalTrials.gov ID: NCT07573488
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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...
- 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
You likely can't join if
- Diagnosis of sleep disorders that could interfere with the sleep intervention, such as obstructive sleep apnea with an apnea-hypopnea index (AHI) \>...
- Current diagnosis of a psychiatric disorder that is inadequately treated or therapy-resistant and may interfere with study participation or adherence...
- 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)
See the full eligibility criteria
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.