Sleep, Circadian Rhythms and Cluster Headache

April 12, 2017 updated by: University of Surrey

Characterisation of Sleep and Circadian Physiology in Individuals With 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Guildford, United Kingdom, GU2 7XP
        • Surrey Clinical Research Centre, University of Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cluster headache sufferers (both of the episodic and chronic cluster headache) Related headache disorders

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cluster headache
Cluster headache sufferers (both chronic and episodic)
Other: Polysomnography
Overnight physiological recording of sleep
Other: Actigraphy
Wristwatch activity to measure basic rest activity cycle and sleep efficiency

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amplitude and phase of circadian rhythm of melatonin
Time Frame: 36 hours
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Surrey

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Alexander D Nesbitt, BM BCh MRCP, University of Surrey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

October 5, 2011

First Posted (Estimate)

October 6, 2011

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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