Normobaric Oxygen (NBO) Therapy in Acute Migraine

February 3, 2017 updated by: Aneesh B. Singhal, MD, Massachusetts General Hospital
This is a pilot study investigating the therapeutic potential of breathing 100% oxygen in acute migraine headache.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
Biological: Oxygen
Oxygen is inhaled for 30 minutes during migraine attack
PLACEBO_COMPARATOR: Room Air
Medical air inhaled for 30 minutes during migraine attack
Biological: Room air
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)
Time Frame: From baseline (0 minutes) to 30 mins

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Score From 0-15 Minutes on the Visual Analogue Scale (VAS)
Time Frame: Baseline (0 minutes) to 15 minutes

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.
Baseline (0 minutes) to 15 minutes
Change in Pain Score From 0-60 Minutes on the Visual Analogue Scale (VAS)
Time Frame: Baseline (0 minutes) to 60 minutes

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.
Baseline (0 minutes) to 60 minutes
Final Pain Severity Score 0-1 on the Visual Analogue Scale (VAS)
Time Frame: 60 minutes

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

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

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

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.
60 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-gas Therapy Medication Use
Time Frame: 60 minutes
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.
60 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Aneesh B Singhal, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

February 29, 2012

First Posted (ESTIMATE)

March 2, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2017

Last Update Submitted That Met QC Criteria

February 3, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009P000380 (OTHER: PHRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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