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

This study is currently recruiting participants.
Verified August 2016 by MD, Ph.d.-student Nunu Lund, Danish Headache Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02853487
First Posted: August 3, 2016
Last Update Posted: August 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
MD, Ph.d.-student Nunu Lund, Danish Headache Center
  Purpose
The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.

Condition Intervention
Cluster Headache Device: Actigraphy Other: Diary

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study

Resource links provided by NLM:


Further study details as provided by MD, Ph.d.-student Nunu Lund, Danish Headache Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Attack occurence [ Time Frame: 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. ]

Estimated Enrollment: 36
Study Start Date: July 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Actigraph from Philips
Other: Diary
Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with episodic cluster headache as defined by ICHD III beta
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853487


Contacts
Contact: Nunu Lund, MD +4538633378 nunu.lund@regionh.dk

Locations
Denmark
Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup Recruiting
Glostrup, Denmark, 2600
Contact: Nunu Lund, MD    +4538633378    nunu.lund@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Rigmor Jensen, Professor Danish Headache Centerq
  More Information

Responsible Party: MD, Ph.d.-student Nunu Lund, MD, PhD-student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02853487     History of Changes
Other Study ID Numbers: H-7-2014-020
First Submitted: July 27, 2016
First Posted: August 3, 2016
Last Update Posted: August 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by MD, Ph.d.-student Nunu Lund, Danish Headache Center:
Cluster headache
actigraphy
circadian rhythm

Additional relevant MeSH terms:
Headache
Cluster Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases