STUDY OBJECTIVES: We hypothesized that early intervention with an auto bilevel device would improve treatment adherence compared to CPAP among OSA patients with a poor initial experience with lab-based CPAP titration. METHODS:Patients with a poor initial CPAP experience were recruited for this parallel group, randomized, double-blind, controlled pilot study. After an in-lab titration, patients were randomized with either an auto-bilevel device or CPAP. Treatment adherence and functioning were assessed at 90 days. RESULTS:We enrolled 51 subjects, with 47 completing the protocol. Groups were equally matched for gender, age, education, and OSA severity. There was no significant difference in the proportion of compliant subjects (≥ 4 h/night) between the auto bilevel and CPAP groups (62% vs. 54%; p = 0.624) after 90 days of use. Functional outcomes significantly improved in both groups during treatment use (p < 0.001) but did not differ between groups. CONCLUSIONS: There was no statistically significant difference in adherence between the auto bilevel and CPAP groups in this study. Patients with a poor initial CPAP exposure may still achieve an acceptable long-term clinical outcome. Both groups demonstrated comparably significant improvements in functional outcomes, sleepiness, and fatigue complaints over the treatment period. CLINICAL TRIALS INFORMATION: NCT00635206 ClinicalTrials.gov
RCT Entities:
STUDY OBJECTIVES: We hypothesized that early intervention with an auto bilevel device would improve treatment adherence compared to CPAP among OSA patients with a poor initial experience with lab-based CPAP titration. METHODS:Patients with a poor initial CPAP experience were recruited for this parallel group, randomized, double-blind, controlled pilot study. After an in-lab titration, patients were randomized with either an auto-bilevel device or CPAP. Treatment adherence and functioning were assessed at 90 days. RESULTS: We enrolled 51 subjects, with 47 completing the protocol. Groups were equally matched for gender, age, education, and OSA severity. There was no significant difference in the proportion of compliant subjects (≥ 4 h/night) between the auto bilevel and CPAP groups (62% vs. 54%; p = 0.624) after 90 days of use. Functional outcomes significantly improved in both groups during treatment use (p < 0.001) but did not differ between groups. CONCLUSIONS: There was no statistically significant difference in adherence between the auto bilevel and CPAP groups in this study. Patients with a poor initial CPAP exposure may still achieve an acceptable long-term clinical outcome. Both groups demonstrated comparably significant improvements in functional outcomes, sleepiness, and fatigue complaints over the treatment period. CLINICAL TRIALS INFORMATION: NCT00635206 ClinicalTrials.gov
Authors: T E Weaver; N B Kribbs; A I Pack; L R Kline; D K Chugh; G Maislin; P L Smith; A R Schwartz; N M Schubert; K A Gillen; D F Dinges Journal: Sleep Date: 1997-04 Impact factor: 5.849
Authors: Christopher L Drake; Ryan Day; David Hudgel; Yevgeniy Stefadu; Mary Parks; Mary Lou Syron; Thomas Roth Journal: Sleep Date: 2003-05-01 Impact factor: 5.849
Authors: Rohit Budhiraja; Sairam Parthasarathy; Christopher L Drake; Thomas Roth; Imran Sharief; Pooja Budhiraja; Victoria Saunders; David W Hudgel Journal: Sleep Date: 2007-03 Impact factor: 5.849
Authors: Barry Krakow; Victor A Ulibarri; Jessica N Sanchez; Shara Kikta; Natalia McIver; Dominic Melendrez Journal: J Clin Sleep Med Date: 2012-06-15 Impact factor: 4.062
Authors: Susheel P Patil; Indu A Ayappa; Sean M Caples; R Joh Kimoff; Sanjay R Patel; Christopher G Harrod Journal: J Clin Sleep Med Date: 2019-02-15 Impact factor: 4.062
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
Authors: Ian M Colrain; Jed Black; Lawrence C Siegel; Richard K Bogan; Philip M Becker; Mehran Farid-Moayer; Rochelle Goldberg; D Alan Lankford; Andrew N Goldberg; Atul Malhotra Journal: Sleep Med Date: 2013-07-17 Impact factor: 3.492