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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT04925414

Run by

Centre Hospitalier Universitaire de Nice

People needed

70

Starts

2023-10-01

Expected to finish

2025-04-01

Last updated by the study team

2024-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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)

Where it is running

• CHU de Nice — Nice, France (enrolling)

Full record on ClinicalTrials.gov

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