search
Back to results

Administration of Oxygen to Cluster Headache Patients

Primary Purpose

Cluster Headache Attacks

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Open Hudson Mask
Cluster headache mask with 3 L reservoir
Mask 3
Carnét oxygen demand valve
Carnét oxygen demand valve
Sponsored by
Mads Barløse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cluster Headache Attacks focused on measuring acute treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Danish Headache Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Mask 1

Mask 2

Mask 3

Mask 3, placebo

Arm Description

Outcomes

Primary Outcome Measures

Efficacy
Pain relief after 15 minutes of treatment

Secondary Outcome Measures

Mask preference
subject mask preference

Full Information

First Posted
April 26, 2012
Last Updated
October 9, 2015
Sponsor
Mads Barløse
search

1. Study Identification

Unique Protocol Identification Number
NCT01589588
Brief Title
Administration of Oxygen to Cluster Headache Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mads Barløse

4. Oversight

5. Study Description

Brief Summary
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cluster Headache Attacks
Keywords
acute treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mask 1
Arm Type
Experimental
Arm Title
Mask 2
Arm Type
Experimental
Arm Title
Mask 3
Arm Type
Experimental
Arm Title
Mask 3, placebo
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Open Hudson Mask
Intervention Description
Mask type 1 oxygen
Intervention Type
Device
Intervention Name(s)
Cluster headache mask with 3 L reservoir
Intervention Description
Mask type 2 with oxygen
Intervention Type
Device
Intervention Name(s)
Mask 3
Intervention Description
Mask type 3 oxygen
Intervention Type
Device
Intervention Name(s)
Carnét oxygen demand valve
Intervention Description
mask type 3 oxygen
Intervention Type
Device
Intervention Name(s)
Carnét oxygen demand valve
Intervention Description
mask type 3 placebo
Primary Outcome Measure Information:
Title
Efficacy
Description
Pain relief after 15 minutes of treatment
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Mask preference
Description
subject mask preference
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Administration of Oxygen to Cluster Headache Patients

We'll reach out to this number within 24 hrs