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

Danish Headache Center

Status: Completed

Conditions: Cluster Headache

Treatments: Device: Actigraphy; Other: Diary

Study type: Observational

Funder types: Other

Identifiers

NCT02853487

H-7-2014-020

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

60 participants in 2 patient groups

Cluster headache patients

Description:

Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks.

Treatment:

Device: Actigraphy

Other: Diary

Control group

Description:

Healthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks.

Treatment:

Device: Actigraphy

Other: Diary