Normobaric Oxygen (NBO) Therapy in Acute Migraine
1 other identifier
interventional
22
1 country
1
Brief Summary
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
March 27, 2017
CompletedMarch 27, 2017
February 1, 2017
3.2 years
February 21, 2012
October 16, 2016
February 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
The mean change in VAS pain scores from 0 minutes to 30 minutes was selected as the primary outcome measure. The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.
From baseline (0 minutes) to 30 mins
Secondary Outcomes (6)
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
Baseline (0 minutes) to 15 minutes
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
Baseline (0 minutes) to 60 minutes
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
60 minutes
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
60 minutes
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
60 minutes
- +1 more secondary outcomes
Other Outcomes (1)
Post-gas Therapy Medication Use
60 minutes
Study Arms (2)
Oxygen
EXPERIMENTALOxygen is inhaled for 30 minutes during migraine attack
Room Air
PLACEBO COMPARATORMedical air inhaled for 30 minutes during migraine attack
Interventions
Eligibility Criteria
You may qualify if:
- Adult subjects with frequent migraine (at least 1 attack per month)
You may not qualify if:
- Secondary (non-migraine) headache
- Chronic obstructive pulmonary disease
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Singhal AB, Maas MB, Goldstein JN, Mills BB, Chen DW, Ayata C, Kacmarek RM, Topcuoglu MA. High-flow oxygen therapy for treatment of acute migraine: A randomized crossover trial. Cephalalgia. 2017 Jul;37(8):730-736. doi: 10.1177/0333102416651453. Epub 2016 May 20.
PMID: 27206964RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Aneesh Singhal, MD
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Aneesh B Singhal, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Neurology
Study Record Dates
First Submitted
February 21, 2012
First Posted
March 2, 2012
Study Start
July 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
March 27, 2017
Results First Posted
March 27, 2017
Record last verified: 2017-02