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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03439722
Other study ID # H-7-2014-020 Sleep study
Secondary ID
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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