Normobaric Oxygen (NBO) Therapy in Acute Migraine

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

Detailed Description
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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.

Official Title
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Normobaric Oxygen (NBO) Therapy in Acute Migraine

Conditions
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Migraine

Intervention / Treatment
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* Biological: Oxygen
* Biological: Room air


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects with frequent migraine (at least 1 attack per month) Exclusion Criteria: Secondary (non-migraine) headache Chronic obstructive pulmonary disease Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen<br>Oxygen is inhaled for 30 minutes during migraine attack | Biological: Oxygen<br>* Oxygen is inhaled for 30 minutes during migraine attack<br>|
| Placebo Comparator: Room Air<br>Medical air inhaled for 30 minutes during migraine attack | Biological: Room air<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (0 minutes) to 15 minutes | 
| 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. | Baseline (0 minutes) to 60 minutes | 
| 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. | 60 minutes | 
| 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. | 60 minutes | 
| 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. | 60 minutes | 
| 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. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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migraine, oxygen therapy