Cluster HeadacheNCT03439722
Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
An observational study of Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Sleep study in episodic cluster headache patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Polysomnography
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jan 2018
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Episodic cluster headache patients diagnosed according to International Classification of Headache disorders III beta (ICHD III beta)
Who may be able to join
- Age between 18 and 65 years of age
- Episodic cluster headache according to ICHD-III beta
- Ability to differentiate attacks of other primary headaches from cluster headache.
- 1-8 daily attacks
- Cluster bouts normally lasting more than 2 weeks
Who cannot join
- Treatment with psychiatric medication other than lithium.
- Pregnancy or breastfeeding
- Serious somatic or psychiatric disorders
- Chronic primary or secondary headache
- Alcohol intake higher than 14 units a week for males and 7 units a week for females.
- Cannot accept the conditions of the trial.
- Does not understand Danish.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
Glostrup Municipality, 2600
About this study
Sleep study in episodic cluster headache patients.
Read the detailed description
This is an explorative study that aims to describe the sleep in 30 episodic cluster headache patients in- and outside of cluster using polysomnography. Data will be compared to a group of healthy controls.
- Conditions
- Cluster Headache
- Being tested
- Polysomnography
- Keywords
- cluster headache, sleep disturbances
- Medical subject headings
- Cluster Headache, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Episodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. Receives: Other: Polysomnography | |
| Controls | Controls will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. Receives: Other: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare total sleep time (hours) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls
Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare rapid eye movement sleep latency (hours) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare prevalence of N1 sleep (%) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare prevalence of N2 sleep (%) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare prevalence of N3 sleep (%) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare prevalence of REM sleep (%) during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare arousals/hour of sleep during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare awakenings/hour of sleep during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses.
Measured: From study initiation to January 2018
Secondary outcomes (1)
The presence of any sleep disorders in patients and controls
Cpmpare the same parameters (Primary outcomes 1-11) in patients and controls. Prevalences will be compared using chi-square tests across categories. If n<5 Mann-Whitney U-test will be used.
Measured: From study initiation to January 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
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-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD, Ph.d.-student Nunu Lund, Danish Headache Center
- Investigators
- Nunu Lund, MD, Principal investigator, Danish Headache Center, Rigshospitalet - Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439722
- Sponsor's protocol ID
- H-7-2014-020 Sleep study
- Status last verified
- Feb 2018
- First submitted
- 27 Jul 2016
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in Cluster Headache: Sleep Parameters in- and Outside a Cluster Bout
- ClinicalTrials.gov ID
- NCT03439722
- Acronym / sponsor ID
- H-7-2014-020 Sleep study
- Conditions
- Cluster Headache
- Keywords
- cluster headache, sleep disturbances
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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.
Sleep study in episodic cluster headache patients.
Detailed description
This is an explorative study that aims to describe the sleep in 30 episodic cluster headache patients in- and outside of cluster using polysomnography. Data will be compared to a group of healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: PolysomnographyEpisodic cluster headache patients will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. |
| Controls | – | Other: PolysomnographyControls will be admitted for 1 night where a polysomnography will be performed by the Danish Center of Sleep Medicine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Episodic cluster headache patients diagnosed according to International Classification of Headache disorders III beta (ICHD III beta)
Key inclusion criteria (5 listed)
- Age between 18 and 65 years of age
- Episodic cluster headache according to ICHD-III beta
- Ability to differentiate attacks of other primary headaches from cluster headache.
- 1-8 daily attacks
- Cluster bouts normally lasting more than 2 weeks
Key exclusion criteria (7 listed)
- Treatment with psychiatric medication other than lithium.
- Pregnancy or breastfeeding
- Serious somatic or psychiatric disorders
- Chronic primary or secondary headache
- Alcohol intake higher than 14 units a week for males and 7 units a week for females.
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 |
|---|---|---|
| PolysomnographyParticipants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography. | Other | Controls, Patients |
Primary outcome
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare total sleep time (hours) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients with healthy controls
Time frame: From study initiation to January 2018
Compare sleep latency (minutes) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare rapid eye movement sleep latency (hours) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare prevalence of N1 sleep (%) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare prevalence of N2 sleep (%) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare prevalence of N3 sleep (%) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare prevalence of REM sleep (%) during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare arousals/hour of sleep during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare awakenings/hour of sleep during one night of polysomnography using mixed models analyses.
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission
Time frame: From study initiation to January 2018
Compare apnea-hypopnea index during one night of polysomnography using mixed models analyses.
1 secondary outcome
The presence of any sleep disorders in patients and controls
Time frame: From study initiation to January 2018
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 20 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Nunu Lund, MD principal investigator
Danish Headache Center, Rigshospitalet - Glostrup
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 Danish Headache Center at 1 site in Denmark.
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 5 inclusion and 7 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 20 Feb 2018. 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 Denmark. 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?
Compare the macrostructure of sleep in episodic cluster headache patients in bout with in remission (time frame: From study initiation to January 2018). The study lists 10 primary outcomes in all. 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 20 Feb 2018.