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Clinical Trials/NCT01447641
NCT01447641
Completed
Not Applicable

Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache

University of Surrey1 site in 1 country8 target enrollmentAugust 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cluster Headache
Sponsor
University of Surrey
Enrollment
8
Locations
1
Primary Endpoint
amplitude and phase of circadian rhythm of melatonin
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2011
End Date
April 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

amplitude and phase of circadian rhythm of melatonin

Time Frame: 36 hours

Study Sites (1)

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