Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx) (MiOx)
Primary Purpose
Migraine
Status
Not yet recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
oxygenotherapy
placebo air aerosol
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
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)
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oxygenotherapy
placebo air aerosol
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Associated symptoms resolution
Associated symptoms (nausea, photophoby, neurological troubles ) resolution
Assess pain level
Simple 0-10 pain verbal numerical rating scale
Occurrence of side effects
Evaluate the occurrence of side effects
Assessing time spent in emergencies
Patient stay in the ED duration
Rescue analgesics usage
The frequency of analgesics administration during patients stay
Full Information
NCT ID
NCT04925414
First Posted
May 17, 2021
Last Updated
July 28, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT04925414
Brief Title
Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
Acronym
MiOx
Official Title
Migraine and High Flow Oxygenotherapy at the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
oxygenotherapy
Arm Type
Experimental
Arm Title
placebo air aerosol
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
oxygenotherapy
Intervention Description
High concentration mask delivering 15L/min of oxygen
Intervention Type
Drug
Intervention Name(s)
placebo air aerosol
Intervention Description
High concentration mask delivering 15L/min of air
Primary Outcome Measure Information:
Title
Pain evaluation
Description
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
30 minutes after aerosol started
Secondary Outcome Measure Information:
Title
Associated symptoms resolution
Description
Associated symptoms (nausea, photophoby, neurological troubles ) resolution
Time Frame
From aerosol start to 90 minutes after
Title
Assess pain level
Description
Simple 0-10 pain verbal numerical rating scale
Time Frame
From 30 minutes after aerosol start to 90 minutes after
Title
Occurrence of side effects
Description
Evaluate the occurrence of side effects
Time Frame
From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours
Title
Assessing time spent in emergencies
Description
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
Title
Rescue analgesics usage
Description
The frequency of analgesics administration during patients stay
Time Frame
From ED admission to exit or transfert assesed up to 6 hours, an average of 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie CONTENTI
Phone
+334.92.03.85.35
Email
contenti.j@chu-ice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie CONTENTI
Phone
+334.92.03.85.35
Email
contenti.j@chu-nice.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No data sharing is planned
Learn more about this trial
Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
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