Normobaric Oxygen (NBO) Therapy in Acute Migraine

Phase 2

Completed

• Conditions: Migraine
• Interventions: Biological: Oxygen; Biological: Room air

• Registration Number: NCT01542307
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-02
• Study Start: 2012-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-10-16
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-03
• Last Update Submitted: 2017-02-03
• Results First Posted: 2017-03-27
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oxygen	Oxygen	Oxygen is inhaled for 30 minutes during migraine attack
Room Air	Room air	Medical air inhaled for 30 minutes during migraine attack

Primary Outcome Measures

Name	Time	Method
Change in Pain Scores From 0-30 Minutes on a Visual Analog Scale (VAS)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States