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Diagnosing nasal obstruction and its common causes using the nasal acoustic device: A pilot study.

ABSTRACT: 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). Conclusion:We have demonstrated that the NAD can help distinguish between normal and abnormal nasal breathing and help diagnose AR, CRS, and DNS. Such a device has not been invented and could revolutionize COVID-19 recovery telemedicine. Level of Evidence:Diagnostic accuracy study-Level III.

SUBMITTER: Li CH

PROVIDER: S-EPMC7461538 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature

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Diagnosing nasal obstruction and its common causes using the nasal acoustic device: A pilot study.

Li Chia-Hung CH Kaura Anika A Tan Calvin C Whitcroft Katherine L KL Leung Terence S TS Andrews Peter P

Laryngoscope investigative otolaryngology 20200828 5

<h4>Objectives</h4>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.<h4>Methods</h4>This pilot study recruited 27 patients with ...[more]

PMID: 32904889

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Project description:ImportanceNasal valve collapse is a primary cause of nasal airway obstruction (NAO). Patients with NAO and nasal valve collapse experience a variety of symptoms that lower their quality of life, such as nasal congestion, headache, sleep disturbance, daytime sleepiness, and snoring.ObjectiveTo determine if active treatment of the nasal valve with a temperature-controlled radiofrequency (TCRF) device, previously demonstrated superior to a sham procedure at 3 months, was safe and associated with sustained improvements in symptoms of NAO through 12 months.Design, setting, and participantsIn a prospective, multicenter, single-blinded, randomized clinical trial, patients in 16 centers in the US with index procedures between August and December 2020 were assigned to TCRF device treatment of the nasal valve or a sham control procedure (no RF energy). Patients had a baseline Nasal Obstruction Symptom Evaluation (NOSE) Scale score of 55 or greater with nasal valve collapse as the primary or substantial contributor to NAO. After primary end point evaluation at 3 months, eligible patients in the sham control arm crossed over to active treatment. Data analysis was performed between April and May 2022.InterventionsPatients were treated bilaterally with the TCRF device at 4 or fewer nonoverlapping areas on the nasal mucosa at the junction of the upper and lower lateral cartilage on the lateral nasal wall.Main outcomes and measuresThe primary end point measure was responder rate, defined as 20% or greater reduction in NOSE Scale score or 1 or greater reduction in NOSE Scale clinical severity category.ResultsA total of 108 patients received active treatment (77 as index active treatment, 31 after crossover). The mean (SD) age of patients was 48.5 (12.3) years; 66 (61.1%) were women. The combined group of patients receiving active treatment had a mean baseline NOSE Scale score of 76.3 (95% CI, 73.6-79.1). At 12 months (n = 88), the responder rate was 89.8% (95% CI, 81.7%-94.5%). The NOSE Scale score improved from baseline (mean change, -44.9 [95% CI, -52.1 to -37.7]). No device/procedure-related serious adverse events were reported.Conclusions and relevanceIn this follow-up of a cohort from a randomized clinical trial, the minimally invasive TCRF device, previously demonstrated to be superior to a sham procedure, was safe and associated with improvement in symptoms of NAO through 12 months postprocedure.Trial registrationClinicalTrials.gov Identifier: NCT04549545.

Project description:BackgroundSeptoplasty (surgery to straighten a deviation in the nasal septum) is a frequently performed operation worldwide, with approximately 250,000 performed annually in the US and 22,000 in the UK. Most septoplasties aim to improve diurnal and nocturnal nasal obstruction. The evidence base for septoplasty clinical effectiveness is hitherto very limited.AimsTo establish, and inform guidance for, the best management strategy for individuals with nasal obstruction associated with a deviated septum.Methods/designA multicentre, mixed-methods, open label, randomised controlled trial of septoplasty versus medical management for adults with a deviated septum and a reduced nasal airway. Eligible patients will have septal deflection visible at nasendoscopy and a nasal symptom score ≥ 30 on the NOSE questionnaire. Surgical treatment comprises septoplasty with or without reduction of the inferior nasal turbinate on the anatomically wider side of the nose. Medical management comprises a nasal saline spray followed by a fluorinated steroid spray daily for six months. The recruitment target is 378 patients, recruited from up to 17 sites across Scotland, England and Wales. Randomisation will be on a 1:1 basis, stratified by gender and severity (NOSE score). Participants will be followed up for 12 months post randomisation. The primary outcome measure is the total SNOT-22 score at 6 months. Clinical and economic outcomes will be modelled against baseline severity (NOSE scale) to inform clinical decision-making. The study includes a recruitment enhancement process, and an economic evaluation.DiscussionThe NAIROS trial will evaluate the clinical effectiveness and cost-effectiveness of septoplasty versus medical management for adults with a deviated septum and symptoms of nasal blockage. Identifying those individuals most likely to benefit from surgery should enable more efficient and effective clinical decision-making, and avoid unnecessary operations where there is low likelihood of patient benefit.Trial registrationEudraCT: 2017-000893-12, ISRCTN: 16168569. Registered on 24 March 2017.

Dataset Information

Diagnosing nasal obstruction and its common causes using the nasal acoustic device: A pilot study.

Publications

Diagnosing nasal obstruction and its common causes using the nasal acoustic device: A pilot study.

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