CHU de Nice
Nice, 06200, France
Location status: Recruiting
Location contact
Céline OCCELLI
CONTACT
Julie CONTENTI
CONTACT
NCT Number: NCT04925414
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Nice, 06200, France
Location status: Recruiting
Céline OCCELLI
CONTACT
Julie CONTENTI
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
High concentration mask delivering 15L/min of oxygen
High concentration mask delivering 15L/min of air
Time frame: 30 minutes after aerosol started
Simple 0-10 pain verbal numerical rating scale (0 being the minimum : no pain, and 10 the maximum : worst pain imaginable by the subject)
Time frame: From aerosol start to 90 minutes after
Associated symptoms (nausea, photophoby, neurological troubles ) resolution
Time frame: From 30 minutes after aerosol start to 90 minutes after
Simple 0-10 pain verbal numerical rating scale
Time frame: From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours
Evaluate the occurrence of side effects
Time frame: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours
Patient stay in the ED duration
Time frame: From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours
The frequency of analgesics administration during patients stay
Contact information is provided by the study sponsor or research team.
Céline OCCELLI
CONTACT
Julie CONTENTI
CONTACT
Centre Hospitalier Universitaire de Nice
Other
Migraine and High Flow Oxygenotherapy at the Emergency Department
Acronym: MiOx
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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