Medical Devices: Evidence and Research (Aug 2019)
The SinuSonic: reducing nasal congestion with acoustic vibration and oscillating expiratory pressure
Abstract
Alyssa Cairns,1 Richard Bogan1–41Sleepmed, Inc., Columbia, SC, USA; 2Bogan Sleep Consultants, LLC, Columbia, SC, USA; 3The University of South Carolina Medical School, Columbia, SC, USA; 4The Medical University of South Carolina, Charleston, SC, USACorrespondence: Alyssa CairnsSleepMed, Inc., 700 Gervais Street, Suite 200, Columbia, SC 29201, USATel +1 803 779 5454Email [email protected]: Nasal congestion is common, burdensome, and costly. Current treatments are limited by partial/temporary relief and untoward side-effects. The goal of this study was to evaluate the performance of a novel, non-pharmacologic nasal device designed to reduce nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.Materials and methods: Patients were recruited from a tertiary care sleep clinic and all reported moderate-to-severe nasal congestion for >2 weeks (N=14; 64% female; 71% Caucasian). Visual analog scale (VAS) (10 items) quantifying nasal congestion and ease-of-breathing were administered before and after SinuSonic application for 2–5 mins. Global and clinical impressions of change were assessed post-administration.Results: Wilcoxon signed-rank tests indicated that post-test ranks were statistically improved from pre-test ranks for both VAS measures (congestion p=0.002; ease-of-breathing p=0.003). A binomial test indicated that the proportion of patients with ≥ minimal improvement on clinical and global impressions of change was higher than expected (100% vs expected 75%, p=0.018).Conclusion: Overall, outcomes were encouraging from this small pilot study with effect sizes in the moderate to large range and no reports of discomfort. It is probable that this device will provide acute, and possibly chronic, relief of nasal congestion with minimal side-effects.Keywords: humming, sinus, congestion
