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Normobaric Oxygen (NBO) Therapy in Acute Migraine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01542307
First received: February 21, 2012
Last updated: February 3, 2017
Last verified: February 2017
Results First Received: October 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Migraine
Interventions: Biological: Oxygen
Biological: Room air

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
22 subjects enrolled

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
22 subjects enrolled - each subject generated data for one or more migraine attacks.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (migraine attacks)

Reporting Groups
  Description
Oxygen-treated Migraine Attacks Oxygen is inhaled for 30 minutes during a migraine attack
Medical Air-treated Migraine Attacks Medical air is inhaled for 30 minutes during a migraine attack

Participant Flow:   Overall Study
    Oxygen-treated Migraine Attacks   Medical Air-treated Migraine Attacks
Participants Units (migraine attacks) Participants Units (migraine attacks)
STARTED   22 [1]   33   22 [2]   31 
COMPLETED   22   33   22   30 
NOT COMPLETED   0      0    
[1] Each subject inhaled Oxygen for 30 minutes in blinded fashion for 2 of the 4 migraine attacks
[2] Each subject inhaled Medical Air for 30 minutes in blinded fashion for 2 of the 4 migraine attacks



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled subjects

Reporting Groups
  Description
Enrolled Subjects Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)

Baseline Measures
   Enrolled Subjects 
Overall Participants Analyzed 
[Units: Participants]
 22 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      20  90.9% 
Male      2   9.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Caucasian   20 
Non-Caucasian   2 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   22 
Migraine 
[Units: Participants]
Count of Participants
 
Migraine w Aura   7 
Migraine without Aura   15 
Employment 
[Units: Participants]
Count of Participants
 
Employed Full Time   17 
Not Employed Full Time   5 
Education Level 
[Units: Participants]
Count of Participants
 
College or higher   20 
School or lower   2 
Marital status 
[Units: Participants]
Count of Participants
 
Married   10 
Single   12 
Smoking Status 
[Units: Participants]
Count of Participants
 
Prior smoker   2 
Non-smoker   20 
Family history of migraine 
[Units: Participants]
Count of Participants
 
Present   13 
Absent   9 
Vascular risk factors (eg. hypertension) 
[Units: Participants]
Count of Participants
 
Present   2 
Absent   20 
One or more lifetime ED visits 
[Units: Participants]
Count of Participants
 
Yes   17 
None   5 
One or more ED visits in prior year 
[Units: Participants]
Count of Participants
 
Visited   11 
Not visited   11 
Triptans for acute migraine 
[Units: Participants]
Count of Participants
 
Using   18 
Not Using   4 
NSAIDs/acetaminophen for acute migraine 
[Units: Participants]
Count of Participants
 
Using   22 
Not Using   0 
Opioids for acute migraine 
[Units: Participants]
Count of Participants
 
Using   6 
Not Using   16 
Anti-seizure meds for migraine prevention 
[Units: Participants]
Count of Participants
 
Using   10 
Not Using   12 
Beta-blockers for migraine prevention 
[Units: Participants]
Count of Participants
 
Using   8 
Not Using   14 
Using botulinum toxin for migraine prevention 
[Units: Participants]
Count of Participants
 
Using   4 
Not Using   18 


  Outcome Measures
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1.  Primary:   Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)   [ Time Frame: From baseline (0 minutes) to 30 mins ]

2.  Secondary:   Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)   [ Time Frame: Baseline (0 minutes) to 15 minutes ]

3.  Secondary:   Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)   [ Time Frame: Baseline (0 minutes) to 60 minutes ]

4.  Secondary:   Final Pain Severity Score 0–1 on the Visual Analogue Scale (VAS)   [ Time Frame: 60 minutes ]

5.  Secondary:   Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)   [ Time Frame: 60 minutes ]

6.  Secondary:   Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)   [ Time Frame: 60 minutes ]

7.  Secondary:   Final Nausea Score 0-1 on the Visual Analog Scale (VAS)   [ Time Frame: 60 minutes ]

8.  Other Pre-specified:   Post-gas Therapy Medication Use   [ Time Frame: 60 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Aneesh Singhal, MD
Organization: Massachusetts General Hospital
phone: 6177268459 ext 4
e-mail: asinghal@partners.org


Publications of Results:

Responsible Party: Aneesh B. Singhal, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01542307     History of Changes
Other Study ID Numbers: 2009P000380
2009P000380 ( Other Identifier: PHRC )
Study First Received: February 21, 2012
Results First Received: October 16, 2016
Last Updated: February 3, 2017