ObvioHealth has partnered with Mi-Helper, Inc. to conduct a remote clinical trial for a non-invasive neuromodulation device designed to treat migraines. The trial will be fully remote, enabling patients to capture data from home using the ObvioGo app, making it accessible to a wider range of patients, including underserved communities.
Mi-Helper has developed a small, drug-free device that delivers a controlled stream of conditioned air with a nebulized mist to the mucosa membranes in the nose, providing relief from migraine-related pain and associated symptoms such as nausea and photosensitivity. The trial features an adaptive design, beginning with the establishment of optimal dosing and culminating in a pivotal trial to determine therapeutic efficacy. ObvioHealth’s COACH team will remotely monitor patient compliance and safety in near real time.