Migraine and High Flow Oxygenotherapy at the Emergency Department (MiOx)
Severe migraines can cause intense head pain, nausea, and extreme sensitivity to light and sound. When regular medicines fail at home, many people have to visit an emergency department (A&E) for help. This clinical trial is exploring a simple, non-drug treatment: breathing high-flow oxygen through a mask. In this trial, adults arriving at hospital with a severe migraine will receive either pure medical oxygen or regular medical air. Neither the patient nor the doctor will know which gas is being given. Researchers will check pain levels on a 0 to 10 scale after 30, 60, and 90 minutes. The main goal is to find out if oxygen lowers pain to a mild level (score of 3 or less) within half an hour. The study will also see if oxygen reduces other symptoms and helps patients go home sooner.
At a glance
What is this study about?
A migraine is much more than a bad headache. It is a neurological condition that causes throbbing pain, often accompanied by feeling sick, vomiting, and sensitivity to bright lights and loud sounds. During a severe attack, standard painkillers often do not work, leading many people to seek urgent medical care at hospital emergency departments.
Doctors already know that breathing pure oxygen works well for another type of headache called a cluster headache. This study aims to find out if high-flow oxygen can also provide rapid relief for people suffering from severe migraine attacks. Because oxygen is simple to give and does not stay in the body like a drug, it could offer a very safe alternative to traditional medicines.
To make sure the results are reliable, this is a 'blinded' study. Half of the participants will receive pure medical oxygen, while the other half will receive compressed medical air, which contains normal levels of oxygen. Both gases look, smell, and feel exactly the same. Doctors will measure whether oxygen genuinely works better than regular air at easing headache pain and calming nausea.
If the study is successful, it could change how emergency departments treat migraines. It may offer patients a fast-acting treatment that gets them home more quickly, avoiding the unpleasant side effects that can come with heavy prescription painkillers.
Key takeaways
- Tests whether high-flow oxygen can rapidly ease severe migraine pain in hospital emergency departments.
- Compares pure medical oxygen against standard compressed air using a face mask.
- Checks if pain levels drop significantly within the first 30 minutes of treatment.
- Open to adults aged 18 and over who attend hospital with a severe migraine.
- Standard emergency migraine medication remains available if the treatment does not help.
Who may be eligible?
You may be able to join this study if you are an adult aged 18 or older and arrive at the emergency department with a severe migraine attack. The trial is open to both men and women.
To take part, your headache must meet the medical definition of a migraine. The hospital medical team will assess your symptoms when you arrive to ensure it is safe and appropriate for you to participate.
People with certain other medical conditions or those experiencing different types of headaches may not be suitable. The emergency room doctors will review your health history before inviting you to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am at least 18 years old.
- I am currently in the emergency department with a severe migraine.
- My headache has not responded to my usual at-home treatments.
- I am able to breathe through an oxygen mask for at least 30 minutes.
- I can rate my pain on a scale from 0 to 10.
What does participation involve?
Taking part in this study takes place entirely during your single visit to the emergency department. You will not need to attend ongoing clinic visits once you leave the hospital.
When you agree to join, you will be given a mask to breathe either pure oxygen or standard medical air. You will be asked to rate your pain on a simple scale from 0 (no pain) to 10 (worst pain possible) before you start, and then again at 30, 60, and 90 minutes. The nursing team will also ask if other symptoms, such as feeling sick or light sensitivity, are getting better.
The initial breathing session lasts around 30 minutes. If your pain does not improve, or if it gets worse at any point, the doctors can give you standard emergency migraine medications straight away. Your safety and comfort always come first.
Potential risks and benefits
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Common questions
What is high-flow oxygen?
It is pure medical oxygen delivered quickly through a comfortable mask to ensure your lungs absorb a high amount of oxygen with every breath.
Will I be left in pain if the gas does not work?
No. If your pain does not improve or becomes unbearable, the emergency team will give you standard migraine painkillers right away.
Can I choose to get pure oxygen instead of air?
No. A computer randomly decides whether you receive oxygen or normal air so that researchers can fairly test if oxygen truly works.
Will I know which gas I received?
Neither you nor your hospital care team will know during the test, as oxygen and normal air feel and smell identical.
Do I have to come back for hospital appointments later?
No. The entire study happens during your emergency department stay and finishes within a few hours.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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