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CompletedNCT02853487Updated Feb 13, 2018

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

An observational study in Cluster Headache, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-13.

Sponsored by Danish Headache Center · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cluster Headache

Keywords

  • Cluster headache
  • actigraphy
  • circadian rhythm
03

In context

Cluster Headache

116 studies on the registry are indexed under Cluster Headache; 27 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 29 observational studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with episodic cluster headache as defined by ICHD III beta

Eligibility 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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Other: Diary

  • Control group

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

    Device: Actigraphy · Other: Diary

Interventions

  • DeviceActigraphy

    An actigraph from Philips

    Also known as: Actigraph from Philips

  • OtherDiary

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

06

What researchers measure

Primary outcomes

  1. Circadian rhythm

    After 2 weeks of actigraphy, the circadian rhythm will be assessed using "Philips Actiware 6" program.

    Time frame: Circadian rhythm is assessed after 2 weeks

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.

07

Study locations

1 site
  • Danish Headache Center, Dept. of Neurology, Rigshospitalet -Glostrup
    Glostrup, 2600, Denmark
08

References and documents

Publications

  • 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. PubMed 30470143 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02853487
Lead sponsor
Danish Headache Center
Responsible party
MD, Ph.d.-student Nunu Lund (MD, PhD-student, Danish Headache Center) — Principal investigator
First posted
Aug 3, 2016
Start date
Jul 2016
Primary completion
Feb 1, 2018
Completion
Feb 1, 2018
Last update
Feb 13, 2018

Study contacts

Rigmor Jensen, Professor
principal investigator · Danish Headache Centerq

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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