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Completed

NCT Number: NCT03439722

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

Sleep study in episodic cluster headache patients.

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Key information

Conditions

Cluster Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Mental Disorders Nervous System Diseases Parasomnias Sleep Wake Disorders Trigeminal Autonomic Cephalalgias

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polysomnography

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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