Objectives: There is a need to develop a medical device which can accurately measure normal and abnormal nasal breathing which the patient can better understand in addition to being able to diagnose the cause for their nasal obstruction. The aim is to evaluate the accuracy of the nasal acoustic device (NAD) in diagnosing the common causes for nasal obstruction and diagnosing normal and abnormal (nasal obstruction) nasal breathing. Methods: This pilot study recruited 27 patients with allergic rhinitis (AR), chronic rhinosinusitis (CRS), and a deviated nasal septum (DNS) which represents the common causes for NO and 26 controls (with normal nasal breathing). Nasal breathing sounds were recorded by the NAD akin to two small stethoscopes placed over the left and right nasal ala. The novel outcome metrics for the NAD include inspiratory nasal acoustic score (INA) score, expiratory nasal acoustic (ENA) score and the inspiratory nasal obstruction balance index (NOBI). The change in acoustic score following decongestant is key in this diagnostic process. Results: Pre-decongestant ENA score was used to detect the presence of nasal obstruction in patients compared to controls, with a sensitivity of 0.81 (95% CI: 0.66-0.96) and a specificity of 0.77 (0.54-1.00). Post-decongestant percentage change in INA score was used to identify the presence of AR or CRS, with a sensitivity of 0.87 (0.69-1.00) and specificity of 0.72 (0.55-0.89) for AR; and a sensitivity of 0.92 (0.75-1.00) and specificity of 0.69 (0.52-0.86) for CRS. Post-decongestant inspiratory NOBI was used to identify DNS, with a sensitivity of 0.77 (0.59-0.95) and specificity of 0.94 (0.82-1.00).
This article aims to demonstrate the concept and potential of a novel diagnostic device -the nasal acoustic device (NAD), which captures the nasal breathing sounds over the ala on both sides of the nose. Using the newly defined inspiratory nasal acoustic score (INA score), the unique characteristics of the nasal breathing sounds can be quantified and used for diagnostic purposes.In this pilot study, the NAD was compared with the well-established nasal inspiratory peak flow meter (NIPF) to try to distinguish between subjects with and without chronic rhinosinusitis (CRS).Measurements were made before and after nasal decongestants, which were applied to eliminate the nasal cycle. Patients were divided into two groups based on the presence or absence of CRS, irrespective of other pathological conditions being present.Based on the post-decongestant measurements, the sensitivity/specificity in distinguishing subjects who have CRS (n=11) from subjects who do not (n=29; of whom 13 were controls) were 70%/66% for the NIPF and 82%/79% for the NAD. The non-CRS groups showed statistically significant changes after decongestant for both methods, but the CRS group did not. The results firstly demonstrated that the CRS subjects in this cohort tended to be less responsive to decongestant and therefore the post-decongestant NIPF measurements provided a certain degree of diagnostic value in identifying CRS subjects, but it would appear the NAD better captured the unique sounds associated with CRS, providing a superior diagnostic capability. This study also demonstrates that the NAD can measure the improvement in the nasal airway following treatment effect.
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