Cooling to Alleviate Migraine #3

NARecruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

March 24, 2025

Primary Completion Date

September 30, 2025

Study Completion Date

December 15, 2025

Conditions
Migraine With or Without AuraMigraineMigraine Headache
Interventions
DEVICE

Mi-Helper

The Mi-Helper device is a non-invasive, drug-free, novel therapy that uses a patented process of dry air flow across the nasal turbinates to induce a phase change (evaporation) that extracts energy (thermodynamics) causing local cooling which modulates nerves associated with pain and other symptoms of migraine. The device delivers a controlled pressure and flow of dry room temperature air along with a nebulized saline mist for added comfort and evaporative efficiency.

Trial Locations (1)

32937

RECRUITING

SPRIM Pro, Indian Harbour Beach

All Listed Sponsors
lead

Mi-Helper, Inc.

INDUSTRY