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Study on the Effectiveness of High-Flow Oxygen Therapy for Migraine Attacks in Emergency Department Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of high-flow oxygen therapy on patients experiencing migraine attacks in emergency departments. A migraine is a type of headache that can cause severe pain, often accompanied by symptoms like nausea and sensitivity to light. The treatment being tested involves the use of oxygen as a medicinal gas, which is inhaled by the patient. The study will compare the effects of this oxygen therapy to a placebo, which is a treatment that looks the same but does not contain the active substance.

The main goal of the study is to determine if high-flow oxygen therapy can effectively reduce the intensity of migraine pain. Participants in the study will receive either the oxygen treatment or a placebo while in the emergency department. The study will monitor the participants' pain levels and any associated symptoms, such as nausea or sensitivity to light, at various times after the treatment begins. The study will also track any side effects and the amount of time participants spend in the emergency department.

This trial aims to provide valuable information on whether high-flow oxygen therapy can be a beneficial treatment for migraines in emergency settings. By understanding the potential benefits and any side effects, the study hopes to improve the management of migraine attacks for patients seeking urgent care.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon arrival at the emergency department, you will be informed about the study and asked to provide written consent to participate. This is necessary to ensure that you understand the study and agree to take part in it.

  2. Step 2

    Initial assessment

    Your eligibility will be confirmed based on your age (18 years or older) and the intensity of your headache, which should be at least 6 on a scale from 0 to 10. This assessment is based on the International Classification of Headaches criteria.

  3. Step 3

    Treatment administration

    You will receive a treatment session with either high-flow oxygen or a placebo (air) through inhalation. This involves breathing in a medicinal gas that is compressed. The session will last for 30 minutes.

  4. Step 4

    Pain assessment

    Thirty minutes after the start of the inhalation treatment, your pain level will be assessed using a simple numerical scale from 0 to 10. The goal is to determine if your pain score is less than or equal to 3.

  5. Step 5

    Symptom monitoring

    Your symptoms, such as nausea or sensitivity to light, will be monitored at 0, 30, 60, and 90 minutes after the start of the session. This helps to track any changes in associated symptoms.

  6. Step 6

    Follow-up assessments

    Further pain assessments will be conducted at 60 and 90 minutes to check for any recurrence of pain. This ensures a comprehensive understanding of the treatment's effectiveness over time.

  7. Step 7

    Side effects and emergency care

    Any side effects experienced during the trial will be recorded. Additionally, the frequency of emergency painkiller use and the average time spent in the emergency room will be documented.

Who can join the trial?

4 criteria

  • Patients must be 18 years of age or older.
  • Must be admitted to the emergency department for a headache that is likely a migraine, based on the guidelines from the International Classification of Headaches, 3rd edition (ICHD-3).
  • Must provide written consent to participate after being informed about the study.
  • The pain intensity must be at least 6 on a scale where the patient rates their own pain.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing a migraine cannot participate. A migraine is a type of headache that can cause severe throbbing pain or a pulsing sensation, usually on one side of the head.
  • Patients who are under the age of 18 or over the age of 65 cannot participate.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, such as those with certain disabilities or conditions.
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Investigated drugs

High-Flow Oxygen Therapy is a treatment that involves delivering oxygen at a higher rate than normal to help relieve symptoms of a migraine. In this trial, the therapy is being tested to see if it can effectively reduce the severity of migraine attacks when patients visit the emergency department. The idea is that by providing more oxygen to the brain, it might help alleviate the pain and other symptoms associated with migraines.

What is already known about the treatment

High Flow Oxygen Therapy – High Flow Oxygen Therapy is administered through a specialized nasal cannula that delivers a high concentration of oxygen directly to the patient. It is currently being studied in clinical trials for its effectiveness in treating migraine attacks in emergency departments. The main therapeutic indication for this therapy is the management of acute migraine episodes. At the molecular level, the therapy works by increasing the oxygen levels in the blood, which may help alleviate the symptoms of a migraine. It is classified as a supportive therapy rather than a traditional pharmacological treatment.

Investigated diseases

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often on one side of the head. These headaches can be accompanied by nausea, vomiting, and sensitivity to light and sound. Migraine attacks can last from a few hours to several days and may occur with varying frequency. Some individuals experience warning symptoms, known as aura, before the onset of a migraine. The progression of a migraine can include a prodrome phase, aura, headache, and postdrome phase. The severity and symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501133-23-00Estimated enrolment70 patientsSponsorCentre Hospitalier Universitaire De Nice

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