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

NCT ID: NCT03439722

Last Updated: 2018-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

Brief Summary

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Sleep study in episodic cluster headache patients.

Detailed Description

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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.

Conditions

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Cluster Headache

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Episodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine.

Polysomnography

Intervention Type OTHER

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

Controls

Controls will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine.

Polysomnography

Intervention Type OTHER

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

Interventions

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Polysomnography

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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MD, Ph.d.-student Nunu Lund

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nunu Lund, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center, Rigshospitalet - Glostrup

Locations

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Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-7-2014-020 Sleep study

Identifier Type: -

Identifier Source: org_study_id

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