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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03439722

Enrollment

Registered

2018-02-20

Start date

2016-01-31

Completion date

2018-01-31

Last updated

2018-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cluster Headache

Keywords

cluster headache, sleep disturbances

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.

Interventions

OTHERPolysomnography

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission	From study initiation to January 2018	Compare total sleep time (hours) 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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026