Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout

Study Overview
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Brief Summary
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Sleep study in episodic cluster headache patients.

Detailed Description
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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.

Official Title
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Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout

Conditions
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Cluster Headache

Intervention / Treatment
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* Other: Polysomnography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Episodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. | Other: Polysomnography<br>* Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.<br>|
| Controls<br>Controls will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. | Other: Polysomnography<br>* Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare total sleep time (hours) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls | Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare rapid eye movement sleep latency (hours) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare prevalence of N1 sleep (%) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare prevalence of N2 sleep (%) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare prevalence of N3 sleep (%) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare prevalence of REM sleep (%) during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare arousals/hour of sleep during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare awakenings/hour of sleep during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 
| Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission | Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses. | From study initiation to January 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of any sleep disorders in patients and controls | 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. | From study initiation to January 2018 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cluster headache, sleep disturbances