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