ObvioHealth and Mi-Helper, Inc. have joined forces to conduct a decentralized clinical trial for a novel, non-invasive device that aims to tackle migraines. This pioneering randomized controlled trial will be fully remote, making it accessible to patients from their homes. The ObvioGo app will be used to enable patients to remotely enroll, consent, and report their progress, while ObvioHealth’s COACH team will monitor patients for safety and compliance in near real-time.
The Mi-Helper device 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. It has been developed to meet a massive unmet need for effective, targeted, and drug-free pain management for migraines, which affects approximately one billion people worldwide. Severe headaches are among the top causes of emergency room outpatient visits in the United States, and a recent study showed that 40% of migraine sufferers were dissatisfied with current treatments due to lack of efficacy, poor tolerability, and contraindications to common migraine-specific medications.
The study will begin with the establishment of optimal dosing and will culminate in a pivotal trial to determine therapeutic efficacy. Mi-Helper and ObvioHealth are committed to inclusivity and have designed a decentralized clinical trial without the need for physical site visits. This will enable patients from anywhere in the continental United States, including underserved communities, to participate, providing Mi-Helper with essential data on a real-world population in a real-world setting. If successful, the device will be able to serve a broad population, delivering fast, accessible, and affordable relief for this highly complex and debilitating neurological disease.