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Sleep, Circadian Rhythms and Cluster Headache

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ClinicalTrials.gov Identifier: NCT01447641
Recruitment Status : Completed
First Posted : October 6, 2011
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Cluster Headache Other: Polysomnography Other: Actigraphy

Study Design

Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache
Study Start Date : August 2011
Primary Completion Date : April 2017
Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. amplitude and phase of circadian rhythm of melatonin [ Time Frame: 36 hours ]

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: October 6, 2011    Key Record Dates
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:
Nervous System Diseases
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Headache
Cluster Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Trigeminal Autonomic Cephalalgias