Sleep, Circadian Rhythms and Cluster Headache
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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 |
Blood hormonal and circulating lymphocyte mRNA assays
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | August 2013 (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 |
Cluster headache sufferers (both of the episodic and chronic cluster headache) Related headache disorders
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| Contact: Alexander D Nesbitt, BM BCh MRCP | A.Nesbitt@surrey.ac.uk |
| 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 | |
| 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: | October 5, 2011 |
| 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:
|
Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Cluster Headache |
Headache Trigeminal Autonomic Cephalalgias Pain Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013