Sleep, Circadian Rhythms and Cluster Headache

NCT ID: NCT01447641

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cluster Headache

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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Cluster headache

Cluster headache sufferers (both chronic and episodic)

Polysomnography

Intervention Type OTHER

Overnight physiological recording of sleep

Actigraphy

Intervention Type OTHER

Wristwatch activity to measure basic rest activity cycle and sleep efficiency

Interventions

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Polysomnography

Overnight physiological recording of sleep

Intervention Type OTHER

Actigraphy

Wristwatch activity to measure basic rest activity cycle and sleep efficiency

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Surrey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander D Nesbitt, BM BCh MRCP

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Locations

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Surrey Clinical Research Centre, University of Surrey

Guildford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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CRC301

Identifier Type: -

Identifier Source: org_study_id

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