Evaluation of a Novel External Neuromodulation Device (iCLEAR™) for the Acute Relief of Rhinitis and Rhinosinusitis Symptoms

Abstract

Methods: This was a multicenter, open-label, single-arm, clinical trial which included adult patients with nasal obstructive symptoms due to chronic rhinitis/rhinosinusitis and a minimum Visual Analog Scale (VAS) score of 25 mm and/or a minimum raw Nasal Obstruction Symptom Evaluation (NOSE) score of 2 on any of items 1, 2, 3, or 5. Enrolled subjects were instructed to apply the study device bilaterally to the external nasal nerve at least three times per day for 30 seconds until the 2-week followup, then twice per day and as needed thereafter. Subjects were evaluated at Days 3, 14, and 30 following the initial baseline visit. The primary efficacy endpoint was the change in nasal obstructive symptoms from baseline to Day 30 as measured by the VAS and NOSE instruments. Safety was assessed by the incidence of device-related Adverse Events (AEs).