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

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ClinicalTrials.gov Identifier: NCT03439722
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
MD, Ph.d.-student Nunu Lund, Danish Headache Center

Brief Summary:
Sleep study in episodic cluster headache patients.

Condition or disease Intervention/treatment
Cluster Headache Other: Polysomnography

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.

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03439722


Locations
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Denmark
Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
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Principal Investigator: Nunu Lund, MD Danish Headache Center, Rigshospitalet - Glostrup
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Responsible Party: MD, Ph.d.-student Nunu Lund, MD, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03439722    
Other Study ID Numbers: H-7-2014-020 Sleep study
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by MD, Ph.d.-student Nunu Lund, Danish Headache Center:
cluster headache
sleep disturbances
Additional relevant MeSH terms:
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Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases