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

NCT03439722 | Completed DMC

• 1 other identifier: H-7-2014-020 Sleep study
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep study in episodic cluster headache patients.

Conditions

Cluster Headache

Keywords

cluster headache; sleep disturbances

Outcome Measures

Primary Outcomes (10)

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

• 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.

  From study initiation to January 2018

Secondary Outcomes (1)

• The presence of any sleep disorders in patients and controls

  From study initiation to January 2018

Study Arms (2)

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

Polysomnography OTHER

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

Controls; Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• daily attacks
• Cluster bouts normally lasting more than 2 weeks

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

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

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Cluster Headache; Parasomnias

Condition Hierarchy (Ancestors)

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

Study Officials

• Nunu Lund, MD

  Danish Headache Center, Rigshospitalet - Glostrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: February 20, 2018
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 20, 2018

Record last verified: 2018-02

Locations

DK (1)