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

NCT ID: NCT02853487

Last Updated: 2018-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-02-01

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.

Conditions

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Cluster Headache

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cluster headache patients

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

Actigraphy

Intervention Type DEVICE

An actigraph from Philips

Diary

Intervention Type OTHER

Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.

Control group

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

Actigraphy

Intervention Type DEVICE

An actigraph from Philips

Diary

Intervention Type OTHER

Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.

Interventions

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Actigraphy

An actigraph from Philips

Intervention Type DEVICE

Diary

Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.

Intervention Type OTHER

Other Intervention Names

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Actigraph from Philips

Eligibility Criteria

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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.


\- Age between 18 and 65 years of age

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


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

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MD, Ph.d.-student Nunu Lund

MD, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rigmor Jensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Centerq

Locations

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Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 30470143 (View on PubMed)

Other Identifiers

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H-7-2014-020

Identifier Type: -

Identifier Source: org_study_id

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