Normobaric Oxygen (NBO) Therapy in Acute Migraine

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital Identifier:
First received: February 21, 2012
Last updated: October 26, 2015
Last verified: October 2015
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Condition Intervention Phase
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:

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: September 2016
Estimated Primary Completion Date: September 2016 (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

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.

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

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
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Please refer to this study by its identifier: NCT01542307

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Aneesh B Singhal, MD Massachusetts General Hospital
  More Information

Responsible Party: Aneesh B. Singhal, MD, Associate Professor of Neurology, Massachusetts General Hospital Identifier: NCT01542307     History of Changes
Other Study ID Numbers: 2009P000380  2009P000380 
Study First Received: February 21, 2012
Last Updated: October 26, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
oxygen therapy

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases processed this record on May 26, 2016