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

Study Overview
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Brief Summary
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The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.

Detailed Description
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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.

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

Conditions
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Cluster Headache

Intervention / Treatment
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* Device: Actigraphy
* Other: Diary


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cluster headache patients<br>Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks. | Device: Actigraphy<br>* An actigraph from Philips<br>* Other names: Actigraph from Philips;Other: Diary<br>* Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.<br>|
| Control group<br>Healthy, headache-free controls will wear an actigraph and fill out a diary for 2 weeks. | Device: Actigraphy<br>* An actigraph from Philips<br>* Other names: Actigraph from Philips;Other: Diary<br>* Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attack occurence |  | The time of day will be assessed after 2 weeks | 
| Physical activity before and during an attack |  | Increase / decrease in activity count will be described after 2 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cluster headache, actigraphy, circadian rhythm