Sleep, Circadian Rhythms and Cluster Headache

NCT01447641 | Completed

• 1 other identifier: CRC301
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache

Keywords

Cluster Headache; Trigeminal Autonomic Cephalalgias; Sleep; Circadian Rhythms

Outcome Measures

Primary Outcomes (1)

• amplitude and phase of circadian rhythm of melatonin

  36 hours

Study Arms (1)

Cluster headache

Cluster headache sufferers (both chronic and episodic)

Other: Polysomnography; Other: Actigraphy

Interventions

Polysomnography OTHER

Overnight physiological recording of sleep

Cluster headache

Actigraphy OTHER

Wristwatch activity to measure basic rest activity cycle and sleep efficiency

Cluster headache

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of cluster headache or closely related primary headache disorder

You may not qualify if:

• Abnormality on screening investigations that increase risk of participation
• Alcohol consumption exceeding 21 units per week

Sponsors & Collaborators

• University of Surrey: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Surrey Clinical Research Centre, University of Surrey

Guildford, GU2 7XP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood hormonal and circulating lymphocyte mRNA assays

MeSH Terms

Conditions

Cluster Headache; Trigeminal Autonomic Cephalalgias

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Accelerometry; Investigative Techniques

Study Officials

• Alexander D Nesbitt, BM BCh MRCP

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2011
• First Posted: October 6, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

GB (1)