OBJECTIVE: We aimed to evaluate the impact of a novel noninvasive oral pressure therapy (OPT) (Winx®, ApniCure) system on polysomnographic measures of sleep-disordered breathing, sleep architecture, and sleep stability in obstructive sleep apnea (OSA). SUBJECTS AND METHODS: A 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial was conducted in five American Academy of Sleep Medicine (AASM) - accredited sleep clinics and one research laboratory. Sixty-three subjects (analysis cohort) were studied from a screening cohort of 367 subjects. The analysis cohort was 69.8% men, ages 53.6±8.9 years (mean±SD), body mass index of 32.3±4.5kg/m(2), with mild to severe OSA. At treatment initiation, subjects received random assignment to one night with and one without (control) treatment, and they were assessed again following 28 nights of treatment. Breathing and sleep architecture were assessed each night based on blind scoring by a single centralized scorer using AASM criteria. RESULTS: Average nightly usage across the take-home period was 6.0±1.4h. There were no severe or serious device-related adverse events (AEs). Median apnea-hypopnea index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour on the first treatment night, and 14.8 events per hour after 28days of treatment. A clinically significant response (treatment AHI ⩽10/h and ⩽50% of control values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, overall stage shifts, total awakenings, and arousals per hour were all significantly reduced at both treatment nights compared to controls. Mean Epworth sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohen d effect size, 0.68) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure (CPAP) therapy to OPT. CONCLUSION: Clinically significant improvements in sleep quality and continuity, AHI, ODI, ESS, and overall clinical status were achieved in an easily identified subgroup. OPT was safe and well-tolerated and nightly usage was high.
RCT Entities:
OBJECTIVE: We aimed to evaluate the impact of a novel noninvasive oral pressure therapy (OPT) (Winx®, ApniCure) system on polysomnographic measures of sleep-disordered breathing, sleep architecture, and sleep stability in obstructive sleep apnea (OSA). SUBJECTS AND METHODS: A 4-week, multicenter, prospective, open-label, randomized, crossover, first-night order of control vs treatment, single-arm trial was conducted in five American Academy of Sleep Medicine (AASM) - accredited sleep clinics and one research laboratory. Sixty-three subjects (analysis cohort) were studied from a screening cohort of 367 subjects. The analysis cohort was 69.8% men, ages 53.6±8.9 years (mean±SD), body mass index of 32.3±4.5kg/m(2), with mild to severe OSA. At treatment initiation, subjects received random assignment to one night with and one without (control) treatment, and they were assessed again following 28 nights of treatment. Breathing and sleep architecture were assessed each night based on blind scoring by a single centralized scorer using AASM criteria. RESULTS: Average nightly usage across the take-home period was 6.0±1.4h. There were no severe or serious device-related adverse events (AEs). Median apnea-hypopnea index (AHI) was 27.5 events per hour on the control night, 13.4 events per hour on the first treatment night, and 14.8 events per hour after 28days of treatment. A clinically significant response (treatment AHI ⩽10/h and ⩽50% of control values) was seen in 20 of the 63 subjects evaluated. Rapid eye movement percentage (REM%) was significantly increased, and N1%, stage shifts to N1 sleep, overall stage shifts, total awakenings, and arousals per hour were all significantly reduced at both treatment nights compared to controls. Mean Epworth sleepiness scale (ESS) was significantly reduced from 12.1 to 8.6 (Cohen d effect size, 0.68) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure (CPAP) therapy to OPT. CONCLUSION: Clinically significant improvements in sleep quality and continuity, AHI, ODI, ESS, and overall clinical status were achieved in an easily identified subgroup. OPT was safe and well-tolerated and nightly usage was high.
Authors: Amit V Patel; Dennis Hwang; Maria J Masdeu; Guo-Ming Chen; David M Rapoport; Indu Ayappa Journal: J Clin Sleep Med Date: 2011-02-15 Impact factor: 4.062
Authors: Shahrokh Javaheri; Mark G Goetting; Rami Khayat; Paul E Wylie; James L Goodwin; Sairam Parthasarathy Journal: Sleep Date: 2011-12-01 Impact factor: 5.849
Authors: Clete A Kushida; Richard B Berry; Alexander Blau; Tami Crabtree; Ingo Fietze; Meir H Kryger; Samuel T Kuna; G Vernon Pegram; Thomas Penzel Journal: Sleep Date: 2011-08-01 Impact factor: 5.849
Authors: Ana Isabel Sánchez; Pilar Martínez; Elena Miró; Wayne A Bardwell; Gualberto Buela-Casal Journal: Sleep Med Rev Date: 2009-02-07 Impact factor: 11.609
Authors: Terri E Weaver; Cristina Mancini; Greg Maislin; Jacqueline Cater; Bethany Staley; J Richard Landis; Kathleen A Ferguson; Charles F P George; David A Schulman; Harly Greenberg; David M Rapoport; Joyce A Walsleben; Teofilo Lee-Chiong; Indira Gurubhagavatula; Samuel T Kuna Journal: Am J Respir Crit Care Med Date: 2012-07-26 Impact factor: 21.405
Authors: Clete A Kushida; Michael R Littner; Max Hirshkowitz; Timothy I Morgenthaler; Cathy A Alessi; Dennis Bailey; Brian Boehlecke; Terry M Brown; Jack Coleman; Leah Friedman; Sheldon Kapen; Vishesh K Kapur; Milton Kramer; Teofilo Lee-Chiong; Judith Owens; Jeffrey P Pancer; Todd J Swick; Merrill S Wise Journal: Sleep Date: 2006-03 Impact factor: 5.849
Authors: Richard J Schwab; C Kim; Lawrence Siegel; B T Keenan; Jed Black; Mehran Farid-Moayer; Jonathan Podmore; Matt Vaska Journal: Sleep Date: 2014-07-01 Impact factor: 5.849