Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
NCT ID: NCT04925414
Last Updated: 2024-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
70 participants
INTERVENTIONAL
2023-10-01
2025-04-30
Brief Summary
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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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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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oxygenotherapy
oxygenotherapy
High concentration mask delivering 15L/min of oxygen
placebo air aerosol
placebo air aerosol
High concentration mask delivering 15L/min of air
Interventions
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oxygenotherapy
High concentration mask delivering 15L/min of oxygen
placebo air aerosol
High concentration mask delivering 15L/min of air
Eligibility Criteria
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Inclusion Criteria
* Affiliated to a french public health insurance
* ED admission for migraine evocative headache, regarding ICHD3 criterions
* written informed consent
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
Responsible Party
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Locations
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CHU de Nice
Nice, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-AOI-08
Identifier Type: -
Identifier Source: org_study_id
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