Administration of Oxygen to Cluster Headache Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mads Barløse, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT01589588
First received: April 26, 2012
Last updated: October 9, 2015
Last verified: October 2015
  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:


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


Enrollment: 57
Study Start Date: April 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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   (Adult)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589588

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

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: October 9, 2015
Health Authority: Denmark: GCP-enheden for Region Hovedstaden

Keywords provided by 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

ClinicalTrials.gov processed this record on July 28, 2016