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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxygenotherapy | Experimental |
| |
| placebo air aerosol | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxygenotherapy | Drug | High concentration mask delivering 15L/min of oxygen |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie CONTENTI | Contact | +334.92.03.85.35 | contenti.j@chu-ice.fr | |
| Céline OCCELLI | Contact | +33492033204 | occelli.c@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nice | Recruiting | Nice | 06200 | France |
No data sharing is planned
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| placebo air aerosol |
| Drug |
High concentration mask delivering 15L/min of air |
|
| 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 |
| D009422 | Nervous System Diseases |