ClinicalTrials.gov
ClinicalTrials.gov Menu

Administration of Oxygen to Cluster Headache Patients

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.
ClinicalTrials.gov Identifier: NCT01589588
Recruitment Status : Completed
First Posted : May 2, 2012
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Mads Barløse, Danish Headache Center

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.

Condition or disease Intervention/treatment Phase
Cluster Headache Attacks Device: Open Hudson Mask Device: Cluster headache mask with 3 L reservoir Device: Mask 3 Device: Carnét oxygen demand valve Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Study Start Date : April 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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
Placebo Comparator: Mask 3, placebo Device: Carnét oxygen demand valve
mask type 3 placebo



Primary Outcome Measures :
  1. Efficacy [ Time Frame: 15 minutes ]
    Pain relief after 15 minutes of treatment


Secondary Outcome Measures :
  1. Mask preference [ Time Frame: 2 days ]
    subject mask preference



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589588


Locations
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Mads Barløse

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
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Keywords provided by Mads Barløse, Danish Headache Center:
acute treatment

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