Cluster HeadacheNCT02853487
Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
An observational study of Cluster Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Actigraphy and Diary
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2016to 1 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with episodic cluster headache as defined by ICHD III beta
Who may be able to join
- Age between 18 and 65 years of age
- Episodic cluster headache
- The patient can differentiate cluster headache from other primary headaches if he suffers from any.
- Age between 18 and 65 years of age
Who cannot join
- Circumstances, determined by the PI, that makes the patient ineligible.
- Changes in preventive medication within 7 days before the study initiation and during the 2 weeks.
- Changes in antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
- Serious somatic and/or psychiatric disorders
- Alcohol intake > 50 units pr.week
- Pregnancy / breastfeeding
Show all 18Show fewer
- Patient cannot accept the conditions of the trial
- Patient does not understand Danish.
- CONTROLS
- Circumstances, determined by the PI, that makes the patient ineligible.
- Any primary headache more than 1 day / month
- Diagnosed with a secondary headache
- Treatment with antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
- Serious somatic and/or psychiatric disorders
- Alcohol intake > 14 / 7 units pr.week (males / females)
- Pregnancy / breastfeeding
- Patient cannot accept the conditions of the trial
- Patient 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
The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.
Read the detailed description
The aim is to investigate circadian rhythm in episodic cluster headache patients in- and outside of bout. This will be done using actigraphy and a short diary for 2 weeks in each period. A secondary outcome is to look at attack occurence and physical activity before and during an attack.
- Conditions
- Cluster Headache
- Being tested
- Actigraphy, Diary
- Keywords
- Cluster headache, actigraphy, circadian rhythm
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActigraphyDevice
Also called Actigraph from Philips
An actigraph from Philips
DiaryOther
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cluster headache patients | Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks. Receives: Device: Actigraphy; Other: Diary | |
| Control group | Healthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks. Receives: Device: Actigraphy; Other: Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythm
After 2 weeks of actigraphy, the circadian rhythm will be assessed using "Philips Actiware 6" program.
Measured: Circadian rhythm is assessed after 2 weeks
Secondary outcomes (2)
Attack occurence
Measured: The time of day will be assessed after 2 weeks
Physical activity before and during an attack
Measured: Increase / decrease in activity count will be described after 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJul 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 60 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
- Rigmor Jensen, Professor, Principal investigator, Danish Headache Centerq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02853487
- Sponsor's protocol ID
- H-7-2014-020
- Status last verified
- Feb 2018
- First submitted
- 27 Jul 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lund NL, Snoer AH, Jennum PJ, Jensen RH, Barloese MCJ. Sleep in cluster headache revisited: Results from a controlled actigraphic study. Cephalalgia. 2019 May;39(6):742-749. doi: 10.1177/0333102418815506. Epub 2018 Nov 23.
PubMed 30470143
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
- ClinicalTrials.gov ID
- NCT02853487
- Acronym / sponsor ID
- H-7-2014-020
- Conditions
- Cluster Headache
- Keywords
- Cluster headache, actigraphy, circadian rhythm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 3 Aug 2016 (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 aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.
Detailed description
The aim is to investigate circadian rhythm in episodic cluster headache patients in- and outside of bout. This will be done using actigraphy and a short diary for 2 weeks in each period. A secondary outcome is to look at attack occurence and physical activity before and during an attack.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cluster headache patients | – | Device: Actigraphy, Other: DiaryEpisodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks. |
| Control group | – | Device: Actigraphy, Other: DiaryHealthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with episodic cluster headache as defined by ICHD III beta
Key inclusion criteria (4 listed)
- Age between 18 and 65 years of age
- Episodic cluster headache
- The patient can differentiate cluster headache from other primary headaches if he suffers from any.
- Age between 18 and 65 years of age
Key exclusion criteria (18 listed)
- Circumstances, determined by the PI, that makes the patient ineligible.
- Changes in preventive medication within 7 days before the study initiation and during the 2 weeks.
- Changes in antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
- Serious somatic and/or psychiatric disorders
- Alcohol intake > 50 units pr.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 |
|---|---|---|
| ActigraphyAlso: Actigraph from PhilipsAn actigraph from Philips | Device | Cluster headache patients, Control group |
| DiaryQuestions on sleep times and awakenings and attacks in the morning and evening for 2 weeks. | Other | Cluster headache patients, Control group |
Primary outcome
Circadian rhythm
Time frame: Circadian rhythm is assessed after 2 weeks
After 2 weeks of actigraphy, the circadian rhythm will be assessed using "Philips Actiware 6" program.
2 secondary outcomes
Attack occurence
Time frame: The time of day will be assessed after 2 weeks
Physical activity before and during an attack
Time frame: Increase / decrease in activity count will be described after 2 weeks.
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 Feb 2018.
- Derived from this study: PubMed 30470143Lund NL, Snoer AH, Jennum PJ, Jensen RH, Barloese MCJ. Sleep in cluster headache revisited: Results from a controlled actigraphic study. Cephalalgia. 2019 May;39(6):742-749. doi: 10.1177/0333102418815506. Epub 2018 Nov 23.
- 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.
Rigmor Jensen, Professor principal investigator
Danish Headache Centerq
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 4 inclusion and 18 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 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?
Circadian rhythm (time frame: Circadian rhythm is assessed after 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02853487, which also lists 1 linked publication.
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 Feb 2018.