Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study

Completed

• Conditions: Cluster Headache
• Interventions: Device: Actigraphy; Other: Diary

• Registration Number: NCT02853487
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-03
• Status Verified: 2018-02
• Primary Completion: 2018-02-01
• Study Completion: 2018-02-01
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cluster headache patients	Diary	Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks.
Control group	Actigraphy	Healthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks.
Control group	Diary	Healthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks.
Cluster headache patients	Actigraphy	Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks.

Primary Outcome Measures

Name	Time	Method
Circadian rhythm	Circadian rhythm is assessed after 2 weeks	After 2 weeks of actigraphy, the circadian rhythm will be assessed using "Philips Actiware 6" program.

Secondary Outcome Measures

Name	Time	Method
Physical activity before and during an attack	Increase / decrease in activity count will be described after 2 weeks.
Attack occurence	The time of day will be assessed after 2 weeks

Trial Locations

Locations (1)

Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup; 🇩🇰 Glostrup, Denmark