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Trial record 14 of 263 for:    Migraine AND Acute Migraine

Normobaric Oxygen (NBO) Therapy in Acute Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01542307
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Aneesh B. Singhal, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Migraine
Interventions Biological: Oxygen
Biological: Room air
Enrollment 22
Recruitment Details 22 subjects enrolled
Pre-assignment Details 22 subjects enrolled - each subject generated data for one or more migraine attacks.
Arm/Group Title Oxygen-treated Migraine Attacks Medical Air-treated Migraine Attacks
Hide Arm/Group Description Oxygen is inhaled for 30 minutes during a migraine attack Medical air is inhaled for 30 minutes during a migraine attack
Period Title: Overall Study
Number of participants Number of units (migraine attacks) Number of participants Number of units (migraine attacks)
Started 22 [1] 33 22 [2] 31
Completed 22 33 22 30
Not Completed 0 0 0 1
[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
Arm/Group Title Enrolled Subjects
Hide Arm/Group Description Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
Enrolled subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
36  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
20
  90.9%
Male
2
   9.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Caucasian
20
  90.9%
Non-Caucasian
2
   9.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
 100.0%
Migraine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Migraine w Aura
7
  31.8%
Migraine without Aura
15
  68.2%
Employment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Employed Full Time
17
  77.3%
Not Employed Full Time
5
  22.7%
Education Level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
College or higher
20
  90.9%
School or lower
2
   9.1%
Marital status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Married
10
  45.5%
Single
12
  54.5%
Smoking Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Prior smoker
2
   9.1%
Non-smoker
20
  90.9%
Family history of migraine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Present
13
  59.1%
Absent
9
  40.9%
Vascular risk factors (eg. hypertension)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Present
2
   9.1%
Absent
20
  90.9%
One or more lifetime ED visits  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Yes
17
  77.3%
None
5
  22.7%
One or more ED visits in prior year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Visited
11
  50.0%
Not visited
11
  50.0%
Triptans for acute migraine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Using
18
  81.8%
Not Using
4
  18.2%
NSAIDs/acetaminophen for acute migraine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Using
22
 100.0%
Not Using
0
   0.0%
Opioids for acute migraine  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Using
6
  27.3%
Not Using
16
  72.7%
Anti-seizure meds for migraine prevention  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Using
10
  45.5%
Not Using
12
  54.5%
Beta-blockers for migraine prevention  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Using
8
  36.4%
Not Using
14
  63.6%
Using botulinum toxin for migraine prevention  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Using
4
  18.2%
Not Using
18
  81.8%
1.Primary Outcome
Title Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
Hide Description

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.

Time Frame From baseline (0 minutes) to 30 mins
Hide Outcome Measure Data
Hide Analysis Population Description
Number of migraine attacks treated with Oxygen or Medical Air
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.38  (1.42) 1.22  (1.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.674
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
Hide Description

The mean change in VAS pain scores from 0 minutes to 15 minutes was selected as a secondary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Time Frame Baseline (0 minutes) to 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.77  (1.09) 0.44  (0.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
Hide Description

The mean change in VAS pain scores from 0 minutes to 60 minutes was selected as a secondary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Time Frame Baseline (0 minutes) to 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.05  (2.23) 1.57  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Final Pain Severity Score 0–1 on the Visual Analogue Scale (VAS)
Hide Description

The percentage of migraine attacks with the final (60 minute) VAS pain score 0-1 was selected as a secondary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Measure Type: Number
Unit of Measure: percentage of attacks
24 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
Hide Description

The percentage of migraine attacks with the final (60 minute) VAS pain score either 0-1, or a 3-point improvement from baseline, was selected as a secondary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Measure Type: Number
Unit of Measure: percentage of attacks
45 23
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
Hide Description

The percentage of migraine attacks with the final (60 minute) VAS visual symptom score 0-1 was selected as a secondary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Measure Type: Number
Unit of Measure: percentage of attacks
36 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
7.Secondary Outcome
Title Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
Hide Description

The percentage of migraine attacks with the final (60 minute) VAS nausea score 0-1 was selected as a secondary outcome measure.

The VAS scale has a range from 0-10 with higher scores indicating greater severity of symptoms.

Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Measure Type: Number
Unit of Measure: percentage of attacks
64 65
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Post-gas Therapy Medication Use
Hide Description The percentage of migraine attacks requiring the use of one or more anti-migraine medications after the period of gas inhalation, was selected as a secondary outcome measure.
Time Frame 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description:

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

Overall Number of Participants Analyzed 22 22
Overall Number of Units Analyzed
Type of Units Analyzed: Migraine attacks
33 31
Measure Type: Number
Unit of Measure: percentage of attacks
36 52
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oxygen, Room Air
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Adverse events were collected from the time of enrollment and until a maximum of 4 migraine attacks were treated with gas inhalation and study equipment returned to the study team.
Adverse Event Reporting Description Specific adverse events ('events of interest') were monitored around the time of each migraine attack (individual subjects had 1-4 migraine attacks each).
 
Arm/Group Title Oxygen Room Air
Hide Arm/Group Description

Oxygen is inhaled for 30 minutes during migraine attack

Oxygen: Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Room air: Placebo

All-Cause Mortality
Oxygen Room Air
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Oxygen Room Air
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oxygen Room Air
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/22 (9.09%)      2/22 (9.09%)    
General disorders     
Dry Mouth   1/22 (4.55%)  1 0/22 (0.00%)  0
Nervous system disorders     
Tingling   1/22 (4.55%)  1 0/22 (0.00%)  0
Significant worsening of migraine headache   0/22 (0.00%)  0 2/22 (9.09%)  2
Indicates events were collected by systematic assessment
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
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 )
First Submitted: February 21, 2012
First Posted: March 2, 2012
Results First Submitted: October 16, 2016
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017