- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439722
Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
February 19, 2018 updated by: MD, Ph.d.-student Nunu Lund, Danish Headache Center
Sleep study in episodic cluster headache patients.
Study Overview
Detailed Description
This is an explorative study that aims to describe the sleep in 30 episodic cluster headache patients in- and outside of cluster using polysomnography.
Data will be compared to a group of healthy controls.
Study Type
Observational
Enrollment (Actual)
66
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Glostrup, Denmark, 2600
- Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Episodic cluster headache patients diagnosed according to International Classification of Headache disorders III beta (ICHD III beta)
Description
Inclusion Criteria:
- Age between 18 and 65 years of age
- Episodic cluster headache according to ICHD-III beta
- Ability to differentiate attacks of other primary headaches from cluster headache.
- 1-8 daily attacks
- Cluster bouts normally lasting more than 2 weeks
Exclusion Criteria:
- Treatment with psychiatric medication other than lithium.
- Pregnancy or breastfeeding
- Serious somatic or psychiatric disorders
- Chronic primary or secondary headache
- Alcohol intake higher than 14 units a week for males and 7 units a week for females.
- Cannot accept the conditions of the trial.
- Does not understand Danish.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients
Episodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine.
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Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.
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Controls
Controls will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine.
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Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare total sleep time (hours) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls
Time Frame: From study initiation to January 2018
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Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare rapid eye movement sleep latency (hours) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare prevalence of N1 sleep (%) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare prevalence of N2 sleep (%) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare prevalence of N3 sleep (%) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare prevalence of REM sleep (%) during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare arousals/hour of sleep during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare awakenings/hour of sleep during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
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Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses.
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From study initiation to January 2018
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The presence of any sleep disorders in patients and controls
Time Frame: From study initiation to January 2018
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Cpmpare the same parameters (Primary outcomes 1-11) in patients and controls.
Prevalences will be compared using chi-square tests across categories.
If n<5 Mann-Whitney U-test will be used.
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From study initiation to January 2018
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nunu Lund, MD, Danish Headache Center, Rigshospitalet - Glostrup
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2016
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
July 27, 2016
First Submitted That Met QC Criteria
February 19, 2018
First Posted (Actual)
February 20, 2018
Study Record Updates
Last Update Posted (Actual)
February 20, 2018
Last Update Submitted That Met QC Criteria
February 19, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-7-2014-020 Sleep study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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