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NCT Number: NCT04925414

Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

oxygenotherapy

Drug

High concentration mask delivering 15L/min of oxygen

placebo air aerosol

Drug

High concentration mask delivering 15L/min of air

Primary outcomes

  1. Pain evaluation

    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)

Secondary outcomes

  1. Associated symptoms resolution

    Time frame: From aerosol start to 90 minutes after

    Associated symptoms (nausea, photophoby, neurological troubles ) resolution

  2. Assess pain level

    Time frame: From 30 minutes after aerosol start to 90 minutes after

    Simple 0-10 pain verbal numerical rating scale

  3. Occurrence of side effects

    Time frame: From aerosol start to ED exit assesed up to 6 hours, an average of 3 hours

    Evaluate the occurrence of side effects

  4. Assessing time spent in emergencies

    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

  5. Rescue analgesics usage

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Céline OCCELLI

CONTACT

[email protected]

+33492033204

Julie CONTENTI

CONTACT

[email protected]

+334.92.03.85.35

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Migraine and High Flow Oxygenotherapy at the Emergency Department

Acronym: MiOx

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2021
Registry last updated
Nov 18, 2024

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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