Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

Centre Hospitalier Universitaire de Nice

Status and phase: Enrolling; Phase 4

Conditions: Migraine

Treatments: Drug: placebo air aerosol; Drug: oxygenotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04925414

20-AOI-08

Details and patient eligibility

About

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.

Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.

However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.

In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.

In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Full description

Migraine is a common pathology, affecting around 12% of the general population, up to 25% in some cohorts, as well as a significant part of the reasons for emergency room visits.

Unlike cluster headaches, the use of high-flow oxygen therapy has not yet been validated in patients with migraine.

However, several aspects of its pathophysiology, still studied to this day, suggest that the use of normobaric oxygen could have beneficial effects on migraine attacks: tissue hypoxia, cerebrovascular dysfunction with vasodilation, inflammation, etc.

In addition, high-flow oxygen therapy has no significant side effects and almost no contraindication (mainly COPD and other chronic respiratory failure) Its use in the event of a migraine attack would thus allow less recourse to conventional analgesics (with significant side effects for some), a shorter stay in the emergency room, and therefore a benefit in terms of cost and relief for the patient.

In this context, the sponsor wish to carry out a multicenter prospective interventional, single-blind randomized placebo-controlled in parallel groups study.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years old or more
• Affiliated to a french public health insurance
• ED admission for migraine evocative headache, regarding ICHD3 criterions
• written informed consent

Exclusion criteria

• COPD or other chronic respiratory failure conditions
• Pregnant or breastfeeding women or women of childbearing potential not using any means of contraception. A pregnancy test will be performed for women of childbearing age. The results will be communicated to the patient by a doctor of her choice.
• Under legal protection
• Patients who have received treatment with triptan in the past 2 weeks
• Patients who have consumed NSAIDs in the hour before the doctor's examination
• State of migraine headache (crippling attack for more than 72 hours)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups, including a placebo group

oxygenotherapy

Experimental group

Treatment:

Drug: oxygenotherapy

placebo air aerosol

Placebo Comparator group

Treatment:

Drug: placebo air aerosol