A new office-based procedure for treatment of snoring: The S.I.Le.N.C.E. study

Laryngoscope Investigative Otolaryngology

article

Michael Friedman¹  M. Boyd Gillespie⁴  Faramarz A. Shabdiz⁵  David H. Hiltzik⁶  Ted A. Meyer⁷  Jeffrey Ahn⁸  Peter J. Catalano^1,10  Ninos J. Joseph³ 

[1] Department of Otolaryngology—Head and Neck Surgery, Rush University Medical Center;Advocate Illinois Masonic Medical Center;ChicagoENT;University of Tennessee Health Science Center;Entrust Medical Group, Department of Otolaryngology—Head and Neck Surgery, St Joseph Hospital;Staten Island University Hospital, Northwell Health;Department of Otolaryngology, MUSC Health-University Medical Center;Park Avenue Sinus & Sleep Center;Perelman School of Medicine, University of Pennsylvania;St. Elizabeth's Medical Center;Department of Otolaryngology, Tufts University School of Medicine

关键词: palatal stiffening;    sleep-disordered breathing;    snoring;    snoring treatment;   

DOI  :  10.1002/lio2.348

学科分类：环境科学（综合）

来源: Wiley

【 摘 要 】

Objective: Demonstrate the safety and effectiveness of palatal foreshortening and stiffening in reducing snoring severity in nonobstructive sleep apnea (non-OSA) patients complaining of chronic disruptive snoring. Methods: In a US-based 8-center, open-label, prospective, single-arm cohort study, 52 consenting adults with chronic disruptive snoring (snoring impacting a patient's life and causing patient or bed partner to seek medical intervention) were treated via officebased placement of resorbable, bidirectional, barbed suture implants into the soft palate under local anesthesia. Prior to intervention, home sleep tests (HSTs) were performed to rule out OSA and to document snoring noise level. Both subject and their bed/sleep partners (also consented) completed questionnaires including: bed/sleep partner's scored visual analog scale (VAS) for subjects' snoring severity, and subject scoring for Epworth Sleepiness Scale (ESS) and Pittsburgh Sleep Quality Index (PSQI). Following intervention, HSTs, VAS, ESS and PSQI were repeated at 30, 90 and 180 days. Results: Mean baseline bed/sleep partner VAS was 7.81 ± 1.59. Mean postimplant VAS scores decreased significantly at each measured interval; to 5.77±2.35 (P < .001) at 30 days, 4.48 ± 1.81 (P < .001) at 90 days, and 5.40 ± 2.28 (P < .001) at 180 days. Post treatment improvements in daytime sleepiness and QOL were also observed. Two partial extrusions were reported. No further adverse events were identified. Conclusion: The current study demonstrates the safety and efficacy of the Elevoplasty procedure in reducing snoring severity over a follow-up period of 6 months.

【 授权许可】

CC BY|CC BY-NC-ND