Clinical trial NCT04925414: Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
Official title: Migraine and High Flow Oxygenotherapy at the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Pain evaluation
timeFrame: 30 minutes after aerosol started
Secondary outcomes:
measure: Associated symptoms resolution
timeFrame: From aerosol start to 90 minutes after
measure: Assess pain level
timeFrame: From 30 minutes after aerosol start to 90 minutes after
measure: Occurrence of side effects
timeFrame: From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours
measure: Assessing time spent in emergencies
timeFrame: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours
measure: Rescue analgesics usage
timeFrame: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
References: