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Normobaric Oxygen (NBO) Therapy in Acute Migraine

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01542307
First received: February 21, 2012
Last updated: October 16, 2014
Last verified: October 2014

February 21, 2012
October 16, 2014
July 2012
September 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01542307 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Normobaric Oxygen (NBO) Therapy in Acute Migraine
Normobaric Oxygen (NBO) Therapy in Acute Migraine

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Migraine
  • Biological: Oxygen
    Oxygen is inhaled for 30 minutes during migraine attack
  • Biological: Room air
    Placebo
  • Experimental: Oxygen
    Oxygen is inhaled for 30 minutes during migraine attack
    Intervention: Biological: Oxygen
  • Placebo Comparator: Room Air
    Medical air inhaled for 30 minutes during migraine attack
    Intervention: Biological: Room air
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
September 2015
September 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary (non-migraine) headache
  • Chronic obstructive pulmonary disease
  • Pregnant
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01542307
2009P000380, 2009P000380
No
Aneesh B. Singhal, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Principal Investigator: Aneesh B Singhal, MD Massachusetts General Hospital
Massachusetts General Hospital
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP