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

Cluster Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02853487
• Other study ID #: H-7-2014-020
• Status: Completed
• Phase: N/A
• First received: July 27, 2016
• Last updated: February 12, 2018
• Start date: July 2016
• Est. completion date: February 1, 2018

Study information

• Verified date: February 2018
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 1, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cluster Headache
• Headache

Intervention

Device:
• Actigraphy
An actigraph from Philips

Other:
• Diary
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.

Locations

Country	Name	City	State
Denmark	Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circadian rhythm	After 2 weeks of actigraphy, the circadian rhythm will be assessed using "Philips Actiware 6" program.	Circadian rhythm is assessed after 2 weeks
Secondary	Attack occurence		The time of day will be assessed after 2 weeks
Secondary	Physical activity before and during an attack		Increase / decrease in activity count will be described after 2 weeks.