Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
Completed
- Conditions
- Cluster Headache
- Interventions
- Other: Polysomnography
- Registration Number
- NCT03439722
- Lead Sponsor
- Danish Headache Center
- Brief Summary
Sleep study in episodic cluster headache patients.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Polysomnography Episodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. Controls Polysomnography Controls will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine.
- Primary Outcome Measures
Name Time Method Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission From study initiation to January 2018 Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls From study initiation to January 2018 Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses.
- Secondary Outcome Measures
Name Time Method The presence of any sleep disorders in patients and controls From study initiation to January 2018 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.
Trial Locations
- Locations (1)
Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
🇩🇰Glostrup, Denmark