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

February 12, 2018 updated by: MD, Ph.d.-student Nunu Lund, Danish Headache Center
The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with episodic cluster headache as defined by ICHD III beta

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cluster headache patients
Episodic cluster headache patients in- and outside of bout will wear an actigraph and fill out a diary for 2 weeks.
Device: Actigraphy
An actigraph from Philips
Other Names:
  • Actigraph from Philips
Other: Diary
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.
Device: Actigraphy
An actigraph from Philips
Other Names:
  • Actigraph from Philips
Other: Diary
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Investigators

  • Principal Investigator: Rigmor Jensen, Professor, Danish Headache Centerq

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 27, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 3, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 12, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-7-2014-020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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