Sleep, Circadian Rhythms and Cluster Headache
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.
|Study Design:||Observational Model: Case-Crossover
Time Perspective: Prospective
|Official Title:||Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache|
- amplitude and phase of circadian rhythm of melatonin [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood hormonal and circulating lymphocyte mRNA assays
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||February 2016|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Cluster headache sufferers (both chronic and episodic)
Overnight physiological recording of sleepOther: Actigraphy
Wristwatch activity to measure basic rest activity cycle and sleep efficiency
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447641
|Contact: Alexander D Nesbitt, BM BCh MRCP||A.Nesbitt@surrey.ac.uk|
|Surrey Clinical Research Centre, University of Surrey||Recruiting|
|Guildford, United Kingdom, GU2 7XP|
|Contact: Alexander Nesbitt A.Nesbitt@surrey.ac.uk|
|Principal Investigator: Alexander D Nesbitt, BM BCh MRCP|
|Principal Investigator:||Alexander D Nesbitt, BM BCh MRCP||University of Surrey|