Sleep, Circadian Rhythms and Cluster Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Surrey
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01447641
First received: October 4, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Cluster Headache
Other: Polysomnography
Other: Actigraphy

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • amplitude and phase of circadian rhythm of melatonin

Biospecimen Retention:   Samples With DNA

Blood hormonal and circulating lymphocyte mRNA assays


Estimated Enrollment: 36
Study Start Date: August 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447641

Contacts
Contact: Alexander D Nesbitt, BM BCh MRCP A.Nesbitt@surrey.ac.uk

Locations
United Kingdom
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         
Sponsors and Collaborators
University of Surrey
University of California, San Francisco
Investigators
Principal Investigator: Alexander D Nesbitt, BM BCh MRCP University of Surrey
  More Information

No publications provided

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01447641     History of Changes
Other Study ID Numbers: CRC301
Study First Received: October 4, 2011
Last Updated: December 19, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Surrey:
Cluster Headache
Trigeminal Autonomic Cephalalgias
Sleep
Circadian Rhythms

Additional relevant MeSH terms:
Cluster Headache
Headache
Headache Disorders
Headache Disorders, Primary
Trigeminal Autonomic Cephalalgias
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014