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

Migraine and High Flow Oxygenotherapy at the Emergency Department

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: oxygenotherapy; Drug: placebo air aerosol

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Julie CONTENTI; Phone Number: +334.92.03.85.35; Email: contenti.j@chu-ice.fr
• Study Contact Backup: Name: Céline OCCELLI; Phone Number: +33492033204; Email: occelli.c@chu-nice.fr

Study Locations

• France
  • Nice, France, 06200
    • Recruiting
    • CHU de Nice
    • Contact: Julie CONTENTI; Phone Number: +334.92.03.85.35; Email: contenti.j@chu-nice.fr
    • Contact: Céline OCCELLI; Phone Number: +33492033204; Email: occelli.c@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: oxygenotherapy	Drug: oxygenotherapy; High concentration mask delivering 15L/min of oxygen
Placebo Comparator: placebo air aerosol	Drug: placebo air aerosol; High concentration mask delivering 15L/min of air

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associated symptoms resolution	Associated symptoms (nausea, photophoby, neurological troubles ) resolution	From aerosol start to 90 minutes after
Assess pain level	Simple 0-10 pain verbal numerical rating scale	From 30 minutes after aerosol start to 90 minutes after
Occurrence of side effects	Evaluate the 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	Patient stay in the ED duration	From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours
Rescue analgesics usage	The frequency of analgesics administration during patients stay	From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 15, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 20-AOI-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data sharing is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No