Normobaric Oxygen (NBO) Therapy in Acute Migraine

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Biological: Oxygen; Biological: Room air

Study type: Interventional

Funder types: Other

Identifiers

NCT01542307

2009P000380 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Oxygen

Experimental group

Description:

Oxygen is inhaled for 30 minutes during migraine attack

Treatment:

Biological: Oxygen

Room Air

Placebo Comparator group

Description:

Medical air inhaled for 30 minutes during migraine attack

Treatment:

Biological: Room air