Administration of Oxygen to Cluster Headache Patients

October 9, 2015 updated by: Mads Barløse
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

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

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

Description

Inclusion Criteria:

  • episodic cluster headache
  • regular occurance of attacks and cluster for 2 years
  • 2-8 attacks / day
  • cluster periods of over 14 days
  • duration of current cluster period max 14 days
  • ability to differentiate between attacks of CH and other forms of headache

Exclusion Criteria:

  • Changes in prophylactic treatment a week before trial
  • pregnancy or breastfeeding women
  • serious somatic or psychiatric disease
  • COLD
  • chronic or primary or secondary headache > 14 days / month other than CH
  • alcohol abuse

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mask 1
Device: Open Hudson Mask
Mask type 1 oxygen
Experimental: Mask 2
Device: Cluster headache mask with 3 L reservoir
Mask type 2 with oxygen
Experimental: Mask 3
Device: Mask 3
Mask type 3 oxygen
Device: Carnét oxygen demand valve
mask type 3 oxygen
Device: Carnét oxygen demand valve
mask type 3 placebo
Placebo Comparator: Mask 3, placebo
Device: Carnét oxygen demand valve
mask type 3 oxygen
Device: Carnét oxygen demand valve
mask type 3 placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 15 minutes
Pain relief after 15 minutes of treatment
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mask preference
Time Frame: 2 days
subject mask preference
2 days

Collaborators and Investigators

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

Sponsor

Mads Barløse

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

April 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 26, 2012

First Submitted That Met QC Criteria

April 30, 2012

First Posted (Estimate)

May 2, 2012

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 9, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2-2011-163

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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