Linda Benoist1, Maurits de Ruiter2, Jan de Lange2, Nico de Vries3. 1. Department of Otorhinolaryngology Head and Neck Surgery, OLVG West, Amsterdam, The Netherlands; Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. Electronic address: l.benoist@erasmusmc.nl. 2. Department of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands; Department of Oral Kinesiology, Amsterdam, The Netherlands. 3. Department of Otorhinolaryngology Head and Neck Surgery, OLVG West, Amsterdam, The Netherlands; Department of Oral Kinesiology, Amsterdam, The Netherlands; Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.
Abstract
OBJECTIVE: To compare the effectiveness of positional therapy (PT) with the sleep position trainer (SPT) to oral appliance therapy (OAT) in patients with mild-to-moderate positional obstructive sleep apnea (POSA). METHODS: Multicenter, prospective, randomized, controlled trial. Patients with mild-to-moderate POSA (apnea-hypopnea index (AHI) ≥5 ≤ 30/hour sleep) were randomized for PT or OAT. Polysomnography was repeated after 3 months. Efficacy, adherence, mean disease alleviation (MDA), quality of life, dropouts and adverse events were evaluated. RESULTS: A total of 177 patients were screened for the study; 99 underwent randomization and 81 completed the study. Intention-to-treat (ITT) analysis of median [IQR] AHI showed a reduction in the PT group from 13.0 [9.7-18.5] to 7.0 [3.8-12.8], p < 0.001 and in the OAT group from 11.7 [9.0-16.2] to 9.1 [4.9-11.7], p < 0.001. Mean adherence (≥4 h/night, ≥5 days/week) was 89.3 ± 22.4% for SPT versus 81.3 ± 30.0% in OAT patients, p = 0.208. CONCLUSIONS:Oral appliance therapy and positional therapy were equally effective in reducing the median AHI in patients with mild-to-moderate POSA. The results of this study have important implications for future OSA treatment guidelines and daily clinical practice. CLINICALTRIALS. GOV NUMBER: NCT02045576.
RCT Entities:
OBJECTIVE: To compare the effectiveness of positional therapy (PT) with the sleep position trainer (SPT) to oral appliance therapy (OAT) in patients with mild-to-moderate positional obstructive sleep apnea (POSA). METHODS: Multicenter, prospective, randomized, controlled trial. Patients with mild-to-moderate POSA (apnea-hypopnea index (AHI) ≥5 ≤ 30/hour sleep) were randomized for PT or OAT. Polysomnography was repeated after 3 months. Efficacy, adherence, mean disease alleviation (MDA), quality of life, dropouts and adverse events were evaluated. RESULTS: A total of 177 patients were screened for the study; 99 underwent randomization and 81 completed the study. Intention-to-treat (ITT) analysis of median [IQR] AHI showed a reduction in the PT group from 13.0 [9.7-18.5] to 7.0 [3.8-12.8], p < 0.001 and in the OAT group from 11.7 [9.0-16.2] to 9.1 [4.9-11.7], p < 0.001. Mean adherence (≥4 h/night, ≥5 days/week) was 89.3 ± 22.4% for SPT versus 81.3 ± 30.0% in OATpatients, p = 0.208. CONCLUSIONS: Oral appliance therapy and positional therapy were equally effective in reducing the median AHI in patients with mild-to-moderate POSA. The results of this study have important implications for future OSA treatment guidelines and daily clinical practice. CLINICALTRIALS. GOV NUMBER: NCT02045576.
Authors: Eric J Kezirian; Michael Simmons; Richard J Schwab; Peter Cistulli; Kasey K Li; Edward M Weaver; Andrew N Goldberg; Atul Malhotra Journal: Am J Respir Crit Care Med Date: 2020-12-01 Impact factor: 21.405
Authors: Richard B Berry; Matthew L Uhles; Brian K Abaluck; David H Winslow; Paula K Schweitzer; Raymond A Gaskins; Robert C Doekel; Helene A Emsellem Journal: J Clin Sleep Med Date: 2019-07-15 Impact factor: 4.062
Authors: Andrea Rossi; Antonino Lo Giudice; Camilla Di Pardo; Alberto Teodoro Valentini; Francesca Marradi; Nicola Vanacore; Cristina Grippaudo Journal: Int J Dent Date: 2021-05-08