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Normobaric Oxygen (NBO) Therapy in Acute Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oxygen
Room air
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring migraine, oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Secondary (non-migraine) headache
  • Chronic obstructive pulmonary disease
  • Pregnant

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxygen

Room Air

Arm Description

Oxygen is inhaled for 30 minutes during migraine attack

Medical air inhaled for 30 minutes during migraine attack

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
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.
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
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.
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
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.
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
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.
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
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.
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
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.

Full Information

First Posted
February 21, 2012
Last Updated
February 3, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01542307
Brief Title
Normobaric Oxygen (NBO) Therapy in Acute Migraine
Official Title
Normobaric Oxygen (NBO) Therapy in Acute Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
migraine, oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxygen
Arm Type
Experimental
Arm Description
Oxygen is inhaled for 30 minutes during migraine attack
Arm Title
Room Air
Arm Type
Placebo Comparator
Arm Description
Medical air inhaled for 30 minutes during migraine attack
Intervention Type
Biological
Intervention Name(s)
Oxygen
Intervention Description
Oxygen is inhaled for 30 minutes during migraine attack
Intervention Type
Biological
Intervention Name(s)
Room air
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
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
Secondary Outcome Measure Information:
Title
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
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
Title
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
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
Title
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
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
Title
Final Pain Score 0-1 or Score Improved 3 or More Points on the Visual Analogue Scale (VAS)
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
Title
Final Visual Symptom Score 0-1 on the Visual Analog Scale (VAS)
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
Title
Final Nausea Score 0-1 on the Visual Analog Scale (VAS)
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
Other Pre-specified Outcome Measures:
Title
Post-gas Therapy Medication Use
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects with frequent migraine (at least 1 attack per month) Exclusion Criteria: Secondary (non-migraine) headache Chronic obstructive pulmonary disease Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aneesh B Singhal, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27206964
Citation
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.
Results Reference
result

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Normobaric Oxygen (NBO) Therapy in Acute Migraine

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