Clinical trial NCT03439722: Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
Official title: Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cluster Headache
Keywords: cluster headache
sleep disturbances
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-02-20
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Episodic cluster headache patients diagnosed according to International Classification of Headache disorders III beta (ICHD III beta)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
measure: Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
timeFrame: From study initiation to January 2018
Secondary outcomes:
measure: The presence of any sleep disorders in patients and controls
timeFrame: From study initiation to January 2018
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
Study officials:
affiliation: Danish Headache Center, Rigshospitalet - Glostrup
name: Nunu Lund, MD
role: PRINCIPAL_INVESTIGATOR
References: