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

Migraine Clinical Trial

— MiOx  

Official title:

Migraine and High Flow Oxygenotherapy at the Emergency Department

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04925414
• Other study ID #: 20-AOI-08
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Julie CONTENTI
• Phone: +334.92.03.85.35
• Email: contenti.j[@]chu-ice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies
• Migraine
• Migraine Disorders

Intervention

Drug:
• oxygenotherapy
High concentration mask delivering 15L/min of oxygen
• placebo air aerosol
High concentration mask delivering 15L/min of air

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Associated symptoms resolution	Associated symptoms (nausea, photophoby, neurological troubles ) resolution	From aerosol start to 90 minutes after
Secondary	Assess pain level	Simple 0-10 pain verbal numerical rating scale	From 30 minutes after aerosol start to 90 minutes after
Secondary	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
Secondary	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
Secondary	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