PArtial REbreathing for Migraine With Aura 1

Inclusion Criteria:

1. Participant has migraine with typical aura (ICHD3 classification 1.2.1) with theadditional criterion that historically in more than 75% of cases of aura a moderateor severe headache begins between 10 and 60 minutes after aura onset.

2. Participant has had 3 or more migraine-with-aura attacks over the last six months.

3. Participant is 18 to 65 years of age.

4. Participant's age at onset of migraine with aura was less than 50 years.

5. If participant is taking migraine prophylactic drugs, the dose must have been stablefor three months or more.

6. Participant agrees to withhold usual acute migraine medications until at least twohours after treatment with the study device.

7. Participant does not plan to initiate new (and/or change existing) migraineprophylaxis medication for the duration of Stage 1 of the study.

8. For female participants: is willing to use adequate contraception during studyparticipation

9. Participant owns a smartphone compatible with the ePRO study diary app.

10. Participant agrees to use the study device as intended, comply with all studyrequirements including treatment, follow-up visits, and recording required studydata in the ePRO app.

11. Participant is willing and able to provide written informed consent.

Exclusion Criteria:

1. Participant has a history of chronic pulmonary disease (e.g. Chronic ObstructivePulmonary Disease (COPD) or pulmonary fibrosis).

2. Participant has a history of severe cardiovascular disease (e.g. symptomaticcoronary artery disease, prior myocardial infarction, congestive heart failure) orcerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomaticcarotid artery disease, prior carotid endarterectomy or other vascular necksurgery).

3. Participant has a history of intracranial hyper/hypo-tension.

4. Participant has a history of cerebral aneurysm.

5. Participant has had previous brain surgery, including stenting.

6. Anaemia, defined as a hemoglobin concentration in capillary blood lower than 11g/dL

7. Participant has a baseline SPO2 level which is lower than 95% performed at SiteVisit 1.

8. Participant has 15 or more headache days per month

9. Participant has medication-overuse headache (ICHD3 classification 8.2).

10. Participant has a known history or suspicion of recurring secondary headache whichin the opinion of the investigator may interfere with the study.

11. Hemiplegic migraine

12. Participant has other significant and relevant pain problem (e.g. cancer pain,fibromyalgia or other head or facial pain disorders)

13. Participant has a known history or suspicion of substance abuse or addiction (withinthe last 5 years) that in the opinion of the investigator may confound the studyassessments.

14. Participant has a history of psychiatric or cognitive disorder and/or behaviouralproblems which in the opinion of the investigator may interfere with the study.

15. Participant belongs to a vulnerable population or has any condition such that his orher ability to provide informed consent, comply with the follow-up requirements, orprovide self-assessments is compromised (e.g. homeless, developmentally disabled,prisoner).

16. For female participants: is pregnant or actively trying to become pregnant.

17. Participant is participating in any other clinical investigation or has participatedin an interventional clinical trial in the preceding 30 days.

18. Participant has any condition that according to the investigator may pose theparticipant at risk or provide confounding data.

19. Participant is unable, as perceived by study personnel, to correctly understand andfollow the instructions for use of the device and ePRO app.

20. Sickle Cell Disease

21. Participant is being treated with nerve blocks or injections for migraineprophylaxis on a regularly scheduled basis (including Botox, Aimovig/Erenumab,Ajovy/Fremanezumab, Emgality/Galcanezumab or Vyepti/Eptinezumab).