Clinical trial NCT02853487: Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
Official title: Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cluster Headache
Keywords: Cluster headache
actigraphy
circadian rhythm
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with episodic cluster headache as defined by ICHD III beta

Brief summary: 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.

Eligibility criteria: PATIENTS

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* Patient cannot accept the conditions of the trial
* Patient does not understand Danish.

CONTROLS

Inclusion Criteria:

- Age between 18 and 65 years of age

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Circadian rhythm
timeFrame: Circadian rhythm is assessed after 2 weeks
Secondary outcomes:
measure: Attack occurence
timeFrame: The time of day will be assessed after 2 weeks
measure: Physical activity before and during an attack
timeFrame: Increase / decrease in activity count will be described after 2 weeks.
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
Study officials:
affiliation: Danish Headache Centerq
name: Rigmor Jensen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.