Cluster HeadacheNCT01447641
Sleep, Circadian Rhythms and Cluster Headache
An observational study of Cluster Headache, run by University of Surrey at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Polysomnography and Actigraphy
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cluster headache sufferers (both of the episodic and chronic cluster headache) Related headache disorders
Who may be able to join
- Diagnosis of cluster headache or closely related primary headache disorder
Who cannot join
- Abnormality on screening investigations that increase risk of participation
- Alcohol consumption exceeding 21 units per week
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Clinical Research Centre, University of Surrey
Guildford, GU2 7XP
About this study
Official title: Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache
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
- Being tested
- Polysomnography, Actigraphy
- Keywords
- Cluster Headache, Trigeminal Autonomic Cephalalgias, Sleep, Circadian Rhythms
- Medical subject headings
- Cluster Headache, Trigeminal Autonomic Cephalalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Overnight physiological recording of sleep
ActigraphyOther
Wristwatch activity to measure basic rest activity cycle and sleep efficiency
| Study group | Role | What they receive |
|---|---|---|
| Cluster headache | Cluster headache sufferers (both chronic and episodic) Receives: Other: Polysomnography; Other: Actigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
amplitude and phase of circadian rhythm of melatonin
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Alexander D Nesbitt, BM BCh MRCP, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447641
- Sponsor's protocol ID
- CRC301
- Status last verified
- Apr 2017
- First submitted
- 4 Oct 2011
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Sleep and Circadian Physiology in Individuals With Cluster Headache
- ClinicalTrials.gov ID
- NCT01447641
- Acronym / sponsor ID
- CRC301
- Conditions
- Cluster Headache
- Keywords
- Cluster Headache, Trigeminal Autonomic Cephalalgias, Sleep, Circadian Rhythms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Aug 2011
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cluster headache | – | Other: Polysomnography, Other: ActigraphyCluster headache sufferers (both chronic and episodic) |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cluster headache sufferers (both of the episodic and chronic cluster headache) Related headache disorders
Key inclusion criteria (1 listed)
- Diagnosis of cluster headache or closely related primary headache disorder
Key exclusion criteria (2 listed)
- Abnormality on screening investigations that increase risk of participation
- Alcohol consumption exceeding 21 units per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyOvernight physiological recording of sleep | Other | Cluster headache |
| ActigraphyWristwatch activity to measure basic rest activity cycle and sleep efficiency | Other | Cluster headache |
Primary outcome
amplitude and phase of circadian rhythm of melatonin
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander D Nesbitt, BM BCh MRCP principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cluster Headache, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amplitude and phase of circadian rhythm of melatonin (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.