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Administration of Oxygen to Cluster Headache Patients

This study is currently recruiting participants.
Verified April 2012 by Danish Headache Center
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
History of Changes
  Purpose

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


Condition Intervention
Cluster Headache Attacks
 Device: Open Hudson Mask
Device: Cluster headache mask with 3 L reservoir
Device: Mask 3
Device: Carnét oxygen demand valve

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Pain relief after 15 minutes of treatment


Secondary Outcome Measures:
  • Mask preference [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    subject mask preference


Estimated Enrollment: 30
Study Start Date: April 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Mask 3, placebo Device: Carnét oxygen demand valve
mask type 3 placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589588

Contacts
Contact: Mads CJ Barløse, MD mads.dhc@hotmail.com

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Mads CJ Barløse, MD         mads.dhc@hotmail.com    
Principal Investigator: Mads CJ Barløse, MD            
Sponsors and Collaborators
Mads Barløse
  More Information

No publications provided

Responsible Party: Mads Barløse, MD, principal investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01589588     History of Changes
Other Study ID Numbers: H-2-2011-163
Study First Received: April 26, 2012
Last Updated: April 30, 2012
Health Authority: Denmark: GCP-enheden for Region Hovedstaden

Keywords provided by Danish Headache Center:
acute treatment

Additional relevant MeSH terms:
Cluster Headache
Headache
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013