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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 17, 2021
Last Updated
July 28, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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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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