PURPOSE: The objective of this study was to evaluate whether a new auto-adjusting bi-level algorithm was comparable to a standard method for prescribing bi-level therapy. METHODS: This study was a prospective randomized, double-blinded crossover evaluation of the equivalency of the auto-adjusting bi-level mode (VAuto™) compared to standard bi-level mode, using a pre-determined difference in Apnea-Hypopnea Index (AHI) of five events per hour. Data were obtained during sleep studies performed on two separate nights. Twenty-two subjects met the entry criteria and were enrolled in the study at four investigational sites in the USA. RESULTS:Mean AHI for the auto-adjusting bi-level mode was 6.2 ± 5.4 events per hour and for the standard bi-level mode 8.3 ± 5.8 events per hour. The AHI for the two modes were clinically equivalent. The difference in median pressure between these two modes was -3.8 cm H(2)O ± 3.6 (p = 0.0008) in favor of the auto-adjusting bi-level mode. In addition, the maximum pressure was significantly higher in the auto-adjusting bi-level mode (16.0 cm H(2)O vs. 14.1 cm H(2)O, p = 0.02). CONCLUSIONS: Our results demonstrated that the auto-adjusting bi-level mode normalized AHI comparable to the standard bi-level mode. The results of this study have several significant implications for the clinical management of sleep apnea. Obstructive sleep apnea (OSA) is a common condition and is associated with untoward complications. Non-compliance with positive airway pressure (PAP) limits the efficacy of the PAP therapy. The auto-adjusting bi-level mode provides a potentially reliable alternative for sleep clinicians faced with prescribing bi-level PAP for non-compliant patients. This study documents that this type of auto-adjusting device provides effective treatment of OSA.
RCT Entities:
PURPOSE: The objective of this study was to evaluate whether a new auto-adjusting bi-level algorithm was comparable to a standard method for prescribing bi-level therapy. METHODS: This study was a prospective randomized, double-blinded crossover evaluation of the equivalency of the auto-adjusting bi-level mode (VAuto™) compared to standard bi-level mode, using a pre-determined difference in Apnea-Hypopnea Index (AHI) of five events per hour. Data were obtained during sleep studies performed on two separate nights. Twenty-two subjects met the entry criteria and were enrolled in the study at four investigational sites in the USA. RESULTS: Mean AHI for the auto-adjusting bi-level mode was 6.2 ± 5.4 events per hour and for the standard bi-level mode 8.3 ± 5.8 events per hour. The AHI for the two modes were clinically equivalent. The difference in median pressure between these two modes was -3.8 cm H(2)O ± 3.6 (p = 0.0008) in favor of the auto-adjusting bi-level mode. In addition, the maximum pressure was significantly higher in the auto-adjusting bi-level mode (16.0 cm H(2)O vs. 14.1 cm H(2)O, p = 0.02). CONCLUSIONS: Our results demonstrated that the auto-adjusting bi-level mode normalized AHI comparable to the standard bi-level mode. The results of this study have several significant implications for the clinical management of sleep apnea. Obstructive sleep apnea (OSA) is a common condition and is associated with untoward complications. Non-compliance with positive airway pressure (PAP) limits the efficacy of the PAP therapy. The auto-adjusting bi-level mode provides a potentially reliable alternative for sleep clinicians faced with prescribing bi-level PAP for non-compliant patients. This study documents that this type of auto-adjusting device provides effective treatment of OSA.
Authors: Marjorie Vennelle; Sandra White; Renata L Riha; Tom W Mackay; Heather M Engleman; Neil J Douglas Journal: Sleep Date: 2010-02 Impact factor: 5.849
Authors: E Shahar; C W Whitney; S Redline; E T Lee; A B Newman; F J Nieto; G T O'Connor; L L Boland; J E Schwartz; J M Samet Journal: Am J Respir Crit Care Med Date: 2001-01 Impact factor: 21.405
Authors: Clete A Kushida; Michael R Littner; Timothy Morgenthaler; Cathy A Alessi; Dennis Bailey; Jack Coleman; Leah Friedman; Max Hirshkowitz; Sheldon Kapen; Milton Kramer; Teofilo Lee-Chiong; Daniel L Loube; Judith Owens; Jeffrey P Pancer; Merrill Wise Journal: Sleep Date: 2005-04 Impact factor: 5.849
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: Terri E Weaver; Greg Maislin; David F Dinges; Thomas Bloxham; Charles F P George; Harly Greenberg; Gihan Kader; Mark Mahowald; Joel Younger; Allan I Pack Journal: Sleep Date: 2007-06 Impact factor: 5.849