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Normobaric Oxygen (NBO) Therapy in Acute Migraine

This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01542307
First received: February 21, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose

This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.


Condition Intervention Phase
Migraine
 Biological: Oxygen
Biological: Room air
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Normobaric Oxygen (NBO) Therapy in Acute Migraine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in Visual Analog Scale (VAS) from 0-30 minutes [ Time Frame: 30 mins ] [ Designated as safety issue: No ]
    Subjects will complete the VAS at 0 minutes, 15 minutes, 30 minutes and 60 minutes after starting gas therapy. The mean change in VAS scores from 0 minutes to 30 minutes will be the primary outcome measure.


Estimated Enrollment: 40
Study Start Date: July 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
 Biological: Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
Placebo Comparator: Room Air
Medical air inhaled for 30 minutes during migraine attack
 Biological: Room air
Placebo

Detailed Description:

A total of 40 adult subjects will be enrolled, male and female. Subjects will be consented to inhale either Normobaric Oxygen (NBO) or Room air for 30 minutes at the start of their migraine attacks. Outcomes will be assessed during and after gas treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects with frequent migraine (at least 1 attack per month)

Exclusion Criteria:

  • Secondary (non-migraine) headache
  • Chronic obstructive pulmonary disease
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542307

Contacts
Contact: Aneesh B Singhal, MD 6177268459 ext 4 asinghal@partners.org
Contact: Megan Aleardi, MPH 6177261884 maleardi@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Aneesh B Singhal, MD     617-726-8459     asinghal@partners.org    
Principal Investigator: Aneesh Singhal, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Aneesh B Singhal, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Aneesh B. Singhal, MD, Associate Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01542307     History of Changes
Other Study ID Numbers: 2009P000380, 2009P000380
Study First Received: February 21, 2012
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
migraine
oxygen therapy

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013