Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04925414

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

Led by Centre Hospitalier Universitaire de Nice · Updated on 2024-11-18

70

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or more
  • Affiliated to a French public health insurance
  • Emergency department admission for headache consistent with migraine according to ICHD3 criteria
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • COPD or other chronic respiratory failure conditions
  • Pregnant or breastfeeding women or women of childbearing potential not using contraception (pregnancy test required for women of childbearing age)
  • Under legal protection
  • Received triptan treatment in the past 2 weeks
  • Consumed NSAIDs in the hour before doctor's examination
  • Migraine headache lasting more than 72 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHU de Nice

Nice, France, 06200

Actively Recruiting

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Research Team

J

Julie CONTENTI

CONTACT

C

Céline OCCELLI

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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