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Completed

NCT Number: NCT02853487

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Actigraphy

Device

An actigraph from Philips

Other names: Actigraph from Philips

Diary

Other

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

Primary outcomes

  1. 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 outcomes

  1. Attack occurence

    Time frame: The time of day will be assessed after 2 weeks

  2. Physical activity before and during an attack

    Time frame: Increase / decrease in activity count will be described after 2 weeks.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 3, 2016
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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