Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

Inclusion Criteria:

1. Age of 18 to 65 years, inclusive of either sex at birth.

2. Lives in the contiguous United States.

3. Self-reported to be able to read and understand English sufficiently to provideinformed consent.

4. Individual has had a diagnosis of episodic migraine with or without aura over atleast 1 year, self-reported during screening.

5. Individual experiences 2 to 8 migraine attacks per month documented via migraineeDiary during screening.

6. Individual is in good reported general health at the time of screening.

7. Migraine onset before 50 years of age, self-reported during screening.

8. Migraine prophylaxis medication unchanged for 4 weeks prior to study enrollment.

9. Stated willingness to comply with all study procedures and availability for theduration of the study.

10. Individuals that own a functioning smartphone device, internet connection (Wi-Fi ordata plan) and are willing to download the study app.

Exclusion Criteria:

1. Participant has difficulty distinguishing his or her migraine attacks fromtension-type headaches.

2. Participant has 15 or more headache days per month reported via migraine eDiary andduring screening.

3. Participant using any opioid medication at the time of screening.

4. Participant has received Botox treatment, barbiturates, supraorbital or occipitalnerve blocks within the last 4 weeks of screening.

5. Participant lives at an altitude of 2000 meters or more above sea level.

6. Self-reported intolerance to intranasal therapy.

7. Self-reported recurrent epistaxis or chronic rhinosinusitis.

8. Self-reported sinus or intranasal surgery within the last 4 months of screening.

9. Self-reported history of 'complicated migraine or headaches' (i.e., hemiplegicmigraine, ophthalmoplegic migraine, migrainous infarction, basilar migraine,post-traumatic headaches, post-concussion syndrome).

10. Known or suspected pregnancy as self-reported by the prospective participant at thetime of screening.

11. Prospective participant unable to fully understand the consent process and provideinformed consent due to either language barriers or mental capacity.

12. Self-reported diagnosis of alcohol or substance abuse disorder at the time ofscreening.

13. Participant with active chronic pain syndromes, such as fibromyalgia, chronic pelvicpain, or complex regional pain syndrome (CRPS); or other pain syndrome liketrigeminal neuralgia.

14. Participant with severe psychiatric conditions (such as major depressive episode,bipolar disorder, major depressive disorder, schizophrenia), dementia, orsignificant neurological disorders (other than migraine) that, in the Investigator'sopinion, might interfere with study assessments.

15. Failure to adhere to or inability to complete Study App inputs and onboardingactivities during the screening period. Participants who are not adherent during thescreening period are not eligible for study entry.

16. Prospective participant has participated in a migraine study or any interventionalclinical study within the 6 months prior to screening.