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Administration of Oxygen to Cluster Headache Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Danish Headache Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mads Barløse, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01589588
First received: April 26, 2012
Last updated: April 30, 2012
Last verified: April 2012

April 26, 2012
April 30, 2012
April 2012
October 2013   (final data collection date for primary outcome measure)
Efficacy [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
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.
 
Recruiting
30
October 2013
October 2013   (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
Both
18 Years to 65 Years
No
Contact: Mads CJ Barløse, MD mads.dhc@hotmail.com
Denmark
 
NCT01589588
H-2-2011-163
Not Provided
Mads Barløse, Danish Headache Center
Mads Barløse
Not Provided
Not Provided
Danish Headache Center
April 2012

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