Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
NCT ID: NCT02853487
Last Updated: 2018-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2016-07-31
2018-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cluster headache patients
Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks.
Actigraphy
An actigraph from Philips
Diary
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.
Control group
Healthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks.
Actigraphy
An actigraph from Philips
Diary
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.
Interventions
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Actigraphy
An actigraph from Philips
Diary
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Danish Headache Center
OTHER
Responsible Party
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MD, Ph.d.-student Nunu Lund
MD, PhD-student
Principal Investigators
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Rigmor Jensen, Professor
Role: PRINCIPAL_INVESTIGATOR
Danish Headache Centerq
Locations
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Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
Glostrup Municipality, , Denmark
Countries
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References
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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.
Other Identifiers
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H-7-2014-020
Identifier Type: -
Identifier Source: org_study_id
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