Evaluation of a Novel External Neuromodulation Device (iCLEAR™) for the Acute Relief of Rhinitis and Rhinosinusitis Symptoms
Author(s): E Mark Shusterman, Michael E Gertner, Anita Carmen Choy, Jacob Johnson, Neil J Friedman
Purpose: To evaluate the efficacy and safety of a novel portable sonic external neuro-stimulation device (iCLEAR) in alleviating symptoms of chronic rhinitis and rhinosinusitis.
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).
Results: In this pilot study of the iCLEAR device, efficacy was indicated by the improvement in rhinitis and rhinosinusitis symptoms on five different scales: Visual Analog Scale, Nasal Obstruction Symptom Evaluation, Total Nasal Symptom Score (TNSS), the Global Assessment of Change (GAC), and the Sino-Nasal Outcome Test (SNOT-20©). On average, the symptom assessment scores showed clinically significant improvement. Mean VAS score decreased to 32.0 (Standard Deviation [SD] = 17.9) from a baseline of 49.6 at 14 days (P = 0.0046) and to 25.5 (20.4) at 30 days. Mean NOSE score decreased to 34.2 (22.5) from 54.6 (25.9) at 30 days (P = 0.006). Mean 12-hour TNSS score decreased to 3.5 (2.3) from 5.1 (2.8) at 30 days (P = 0.038) and mean 14-day TNSS score decreased to 4.3 (2.1) from 5.5 (2.7). Mean GAC