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

February 19, 2018 updated by: MD, Ph.d.-student Nunu Lund, Danish Headache Center
Sleep study in episodic cluster headache patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Glostrup, Denmark, 2600
        • Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Episodic cluster headache patients diagnosed according to International Classification of Headache disorders III beta (ICHD III beta)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Episodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine.
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.
Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare total sleep time (hours) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls
Time Frame: From study initiation to January 2018
Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare rapid eye movement sleep latency (hours) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare prevalence of N1 sleep (%) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare prevalence of N2 sleep (%) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare prevalence of N3 sleep (%) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare prevalence of REM sleep (%) during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare arousals/hour of sleep during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare awakenings/hour of sleep during one night of polysomnography using mixed models analyses.
From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time Frame: From study initiation to January 2018
Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses.
From study initiation to January 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The presence of any sleep disorders in patients and controls
Time Frame: 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.
From study initiation to January 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nunu Lund, MD, Danish Headache Center, Rigshospitalet - Glostrup

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

February 19, 2018

First Posted (Actual)

February 20, 2018

Study Record Updates

Last Update Posted (Actual)

February 20, 2018

Last Update Submitted That Met QC Criteria

February 19, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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