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Administration of Oxygen to Cluster Headache Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01589588
First Posted: May 2, 2012
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mads Barløse, Danish Headache Center
April 26, 2012
May 2, 2012
October 12, 2015
April 2012
December 2014   (Final data collection date for primary outcome measure)
Efficacy [ Time Frame: 15 minutes ]
Pain relief after 15 minutes of treatment
Same as current
Complete list of historical versions of study NCT01589588 on ClinicalTrials.gov Archive Site
Mask preference [ Time Frame: 2 days ]
subject mask preference
Same as current
Not Provided
Not Provided
 
Administration of Oxygen to Cluster Headache Patients
Not Provided
This study will investigate the possible difference in treatment effect between three different oxygen delivery systems in the acute treatment of cluster headaches.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Cluster Headache Attacks
  • Device: Open Hudson Mask
    Mask type 1 oxygen
  • Device: Cluster headache mask with 3 L reservoir
    Mask type 2 with oxygen
  • 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
  • Experimental: Mask 1
    Intervention: Device: Open Hudson Mask
  • Experimental: Mask 2
    Intervention: Device: Cluster headache mask with 3 L reservoir
  • Experimental: Mask 3
    Interventions:
    • Device: Mask 3
    • Device: Carnét oxygen demand valve
  • Placebo Comparator: Mask 3, placebo
    Intervention: Device: Carnét oxygen demand valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
December 2014
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01589588
H-2-2011-163
Not Provided
Not Provided
Not Provided
Mads Barløse, Danish Headache Center
Mads Barløse
Not Provided
Not Provided
Danish Headache Center
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP