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CompletedNCT03439722Updated Feb 20, 2018

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

An observational study in Cluster Headache, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-02-20.

Sponsored by Danish Headache Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
66
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Sleep study in episodic cluster headache patients.

Read the 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.

02

Conditions studied

  • Cluster Headache

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Keywords

  • cluster headache
  • sleep disturbances
03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's enrollment of 66 is close to the median of 68 across 32 observational studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.

Browse Danish Headache Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients

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

    Other: Polysomnography

  • Controls

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

    Other: Polysomnography

Interventions

  • OtherPolysomnography

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From study initiation to January 2018

  2. 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.

    Time frame: From study initiation to January 2018

  3. 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.

    Time frame: From study initiation to January 2018

  4. 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.

    Time frame: From study initiation to January 2018

  5. 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.

    Time frame: From study initiation to January 2018

  6. 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.

    Time frame: From study initiation to January 2018

  7. 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.

    Time frame: From study initiation to January 2018

  8. 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.

    Time frame: From study initiation to January 2018

  9. 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.

    Time frame: From study initiation to January 2018

  10. 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.

    Time frame: From study initiation to January 2018

Secondary outcomes

  1. 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.

    Time frame: From study initiation to January 2018

07

Study locations

1 site
  • Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
    Glostrup, 2600, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Jan 2018, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 27, 2016
First posted
Feb 20, 2018
StartActual
Jan 2016
Primary completionActual
Jan 2018
CompletionActual
Jan 2018
Last update
Feb 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03439722
Lead sponsor
Danish Headache Center
Responsible party
MD, Ph.d.-student Nunu Lund (MD, Danish Headache Center) — Principal investigator
First posted
Feb 20, 2018
Start date
Jan 2016
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Feb 20, 2018

Study contacts

Nunu Lund, MD
principal investigator · Danish Headache Center, Rigshospitalet - Glostrup

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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