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

NCT04925414 | Recruiting Phase 4

• 1 other identifier: 20-AOI-08
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Pain evaluation

  Simple 0-10 pain verbal numerical rating scale (0 being the minimum : no pain, and 10 the maximum : worst pain imaginable by the subject)

  30 minutes after aerosol started

Secondary Outcomes (5)

• Associated symptoms resolution

  From aerosol start to 90 minutes after

• Assess pain level

  From 30 minutes after aerosol start to 90 minutes after

• Occurrence of side effects

  From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours

• Assessing time spent in emergencies

  From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours

• Rescue analgesics usage

  From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours

Study Arms (2)

oxygenotherapy

EXPERIMENTAL

Drug: oxygenotherapy

placebo air aerosol

PLACEBO COMPARATOR

Drug: placebo air aerosol

Interventions

oxygenotherapy DRUG

High concentration mask delivering 15L/min of oxygen

oxygenotherapy

placebo air aerosol DRUG

High concentration mask delivering 15L/min of air

placebo air aerosol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06200, France

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Julie CONTENTI

CONTACT

+334.92.03.85.35; contenti.j@chu-ice.fr

Céline OCCELLI

CONTACT

+33492033204; occelli.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: June 14, 2021
• Study Start: October 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)