NCT02853487

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

July 27, 2016

Last Update Submit

February 12, 2018

Conditions

Cluster Headache

Keywords

Cluster headacheactigraphycircadian rhythm

Outcome Measures

Primary Outcomes (1)

  • Circadian rhythm

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

    Circadian rhythm is assessed after 2 weeks

Secondary Outcomes (2)

  • Attack occurence

    The time of day will be assessed after 2 weeks

  • Physical activity before and during an attack

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

Study Arms (2)

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: ActigraphyOther: Diary

Control group

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

Device: ActigraphyOther: Diary

Interventions

ActigraphyDEVICE

An actigraph from Philips

Also known as: Actigraph from Philips
Cluster headache patientsControl group
DiaryOTHER

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

Cluster headache patientsControl group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with episodic cluster headache as defined by ICHD III beta

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • \- Age between 18 and 65 years of age
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 30470143DERIVED

MeSH Terms

Conditions

Cluster Headache

Interventions

Actigraphy

Condition Hierarchy (Ancestors)

Trigeminal Autonomic CephalalgiasHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisAccelerometryInvestigative Techniques

Study Officials

  • Rigmor Jensen, Professor

    Danish Headache Centerq

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD-student

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 3, 2016

Study Start

July 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

DK(1)