Skip to main content
OpenTrials
Completed

NCT Number: NCT01447641

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Surrey Clinical Research Centre, University of Surrey

Guildford, GU2 7XP, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Other

Overnight physiological recording of sleep

Actigraphy

Other

Wristwatch activity to measure basic rest activity cycle and sleep efficiency

Primary outcomes

  1. amplitude and phase of circadian rhythm of melatonin

    Time frame: 36 hours

Sponsors and collaborators

Lead sponsor

University of Surrey

Other

Collaborators

  • University of California, San Francisco

Registry information

Official study title

Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 6, 2011
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.