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

Cluster Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439722
• Other study ID #: H-7-2014-020 Sleep study
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: February 19, 2018
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2018
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sleep study in episodic cluster headache patients.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Other:
• Polysomnography
Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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