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Sleep, Circadian Rhythms and Cluster Headache

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01447641
First Posted: October 6, 2011
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
University of Surrey
  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 [ Time Frame: 36 hours ]

Biospecimen Retention:   Samples With DNA
Blood hormonal and circulating lymphocyte mRNA assays

Enrollment: 8
Study Start Date: August 2011
Study Completion Date: April 2017
Primary Completion Date: April 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447641


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

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01447641     History of Changes
Other Study ID Numbers: CRC301
First Submitted: October 4, 2011
First Posted: October 6, 2011
Last Update Posted: April 13, 2017
Last Verified: April 2017

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

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


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