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A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion.

ABSTRACT: BACKGROUND:Chronic nasal congestion affects 20% of the population with significant impact on quality of life. This study investigated the simultaneous administration of nasal acoustic vibration and oscillating expiratory pressure for the treatment of nasal congestion. METHODS:Patients with chronic nasal congestion but without fixed anatomic obstruction participated in a prospective clinical study applying simultaneous acoustic vibrations and positive expiratory pressure to the nasal cavity twice daily over 5 weeks. Safety was assessed by rhinoscopy and patient questionnaires. Efficacy was assessed using peak nasal inspiratory flow (PNIF), visual analogue scale (VAS) of nasal symptoms, Total Nasal Symptom Score (TNSS), Nasal Obstruction and Septoplasty Effectiveness (NOSE) score, and the 22-item Sino-Nasal Outcome Test (SNOT-22). RESULTS:Forty patients (mean age 39 years, 65% female) completed the study with no adverse effects. At the 2 week follow-up, PNIF improved by 25.0 L/min (31% increase from baseline, p < 0.001). At the 5 week follow-up, nasal congestion VAS improved from mean ± SD of 5.8 ± 2.4 to 2.6 ± 2.3, TNSS improved from 7.2 ± 3.5 to 3.5 ± 3.1, NOSE improved from 50.4 ± 19.9 to 23.3 ± 17.2, and SNOT-22 improved from 31.7 ± 20.3 to 14.2 ± 12.7, all p < 0.001. Eighty percent of patients would use the device again and 87.5% would recommend to others. CONCLUSION:Simultaneous administration of acoustic vibration and oscillating expiratory pressure appears to be a safe treatment for chronic nasal congestion. Results from this initial study are promising with regard to efficacy but will require further study.

SUBMITTER: Soler ZM

PROVIDER: S-EPMC7317541 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion.

Soler Zachary M ZM Nguyen Shaun A SA Salvador Craig C Lackland Thomas T Desiato Vincent M VM Storck Kristina K Schlosser Rodney J RJ

International forum of allergy & rhinology 20200227 5

<h4>Background</h4>Chronic nasal congestion affects 20% of the population with significant impact on quality of life. This study investigated the simultaneous administration of nasal acoustic vibration and oscillating expiratory pressure for the treatment of nasal congestion.<h4>Methods</h4>Patients with chronic nasal congestion but without fixed anatomic obstruction participated in a prospective clinical study applying simultaneous acoustic vibrations and positive expiratory pressure to the nas ...[more]

PMID: 32104962

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Project description:Study objectivesEvaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure (EPAP) device used to treat obstructive sleep apnea (OSA).DesignA prospective, multicenter, single-arm, open-label extension to a 3-month EPAP vs sham randomized clinical trialSetting13 sites including both academic and private sleep disorder centersPatientsOSA patients in the EPAP arm of the EPAP vs sham randomized study who used the EPAP device ≥ 4 h per night, ≥ 5 nights per week on average during months 1 and 2 of the 3-month trial and had ≥ 50% reduction in AHI or AHI reduction to < 10 documented by polysomnography, comparing the 3-month device-on PSG to the week-one device-off PSG.InterventionsTreatment with a nasal EPAP device (N = 41) for 12 months. Polysomnography (PSG) on the patients wearing the device was performed after 12 months of treatment. The month 12 device-on PSG data from the analyzable subject cohort (N = 34) was compared to the week 1 device-off PSG from the EPAP vs sham trial.Measurements and resultsOf the 51 patients eligible, 34 were still using the EPAP device at the end of 12 months. Median AHI was reduced from 15.7 to 4.7 events/h (week 1 device-off versus month 12 device-on). The decrease in the AHI (median) was 71.3% (p < 0.001). The median proportion of sleep time with snoring was reduced by 74.4% (p < 0.001). Over 12 months of EPAP treatment, the Epworth Sleepiness Scale decreased (11.1 ± 4.2 to 6.0 ± 3.2, p < 0.001), and the median percentage of reported nights used (entire night) was 89.3%.ConclusionsNasal EPAP significantly reduced the AHI, improved subjective daytime sleepiness and reduced snoring after 12 months of treatment. Long-term adherence to EPAP was excellent in those who had a positive clinical response at month 3 of the EPAP vs sham study.Clinical trial registrationClinicalTrials.gov TRIAL NAME: Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea (AERO C009E). URL: http://clinicaltrials.gov/ct2/show/NCT00849043?term=Ventus+Medical&rank=2.Registration numberNCT00849043.

Dataset Information

A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion.

Publications

A novel device combining acoustic vibration with oscillating expiratory pressure for the treatment of nasal congestion.

Similar Datasets

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