NCT04925414RecruitingPhase 4
Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
Migraine and High Flow Oxygenotherapy at the Emergency Department
Source: ClinicalTrials.gov · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 17 May 2021
- Start date
- 1 Oct 2023
- Primary completion date
- Apr 2025
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Migraine
- NCT number
- NCT04925414
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 70
- From 1 Oct 2023 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received treatment with triptan in the past 2 weeks
Other illness
- COPD or other chronic respiratory failure conditions
Age
- 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.
Other
- Under legal protection
- Patients who have consumed NSAIDs in the hour before the doctor's examination
- State of migraine headache (crippling attack for more than 72 hours)
Who the study is looking for
- 18 years old or more
- Affiliated to a french public health insurance
- ED admission for migraine evocative headache, regarding ICHD3 criterions
- written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.