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RECRUITING
NCT04925414
PHASE4

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

Sponsor: Centre Hospitalier Universitaire de Nice

View on ClinicalTrials.gov

Summary

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.

Official title: Migraine and High Flow Oxygenotherapy at the Emergency Department

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2023-10-01

Completion Date

2025-04

Last Updated

2024-11-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

oxygenotherapy

High concentration mask delivering 15L/min of oxygen

DRUG

placebo air aerosol

High concentration mask delivering 15L/min of air

Locations (1)

CHU de Nice

Nice, France