Sleep, Circadian Rhythms and Cluster Headache

Cluster Headache Clinical Trial

Official title:

Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447641
• Other study ID #: CRC301
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: April 12, 2017
• Start date: August 2011
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: University of Surrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess both the sleep and circadian (24-hourly biological rhythms) physiology of people with cluster headache. For sufferers with the episodic form of the disorder this will involve observation at two separate time points, once when experiencing attacks (in-bout) and once when attack free (out-of-bout).

The study will include measurement of basic rest-activity patterns, sleep timing and timing of individual attacks, as well as a more detailed study recording sleep and circadian rhythms under clinical conditions over consecutive nights.

Studying the differences in these processes in single individuals when they are both experiencing and free from attacks might provide insight into the brain mechanisms involved in triggering the bouts of attacks and individual attacks themselves. An improved understanding of this area may help design improved treatment options in future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of cluster headache or closely related primary headache disorder

Exclusion Criteria:

• Abnormality on screening investigations that increase risk of participation

• Alcohol consumption exceeding 21 units per week

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Other:
• Polysomnography
Overnight physiological recording of sleep
• Actigraphy
Wristwatch activity to measure basic rest activity cycle and sleep efficiency

Locations

Country	Name	City	State
United Kingdom	Surrey Clinical Research Centre, University of Surrey	Guildford

Sponsors (2)

Lead Sponsor	Collaborator
University of Surrey	University of California, San Francisco

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amplitude and phase of circadian rhythm of melatonin		36 hours