Clinical Benefits & The Löwenstein Difference

S A N T È • LÖW E N S T E I N S L E E P T H E R A PY D E V I C E S

Appendix 5

technology

Study Hunter: APAP effectiveness in prisma Extended evaluation of the efficacy of a proactive forced oscillation technique-based auto-CPAP algorithm S. D. Herkenrath, M. Treml, N. Anduleit, K. Richter, A. Pietzke-Calcagnile, M. Schwaibold, R. Schäfer, R. Alshut, A. Grimm, L. Hagmeyer, W. J. Randerath, Sleep and Breathing, https://doi.org/10.1007/s11325-019-01901-8 Background: As published by Zhu et. al there are significant differences in the efficacy of APAP devices. 1 There are also limitations to APAP in favor of CPAP (e.g. blood pressure reduction), that is why a reliable pressure regulation is even more important. The Forced Oscillation Technique (FOT) is a proven method for reliable apnea classification to ensure adequate pressure regulation in APAP devices. In a prospective, interventional trial the APAP mode in prisma was examined regarding: - The effectiveness of pressure regulation in terms of evaluating upper airway obstructions, - Flow contour analyses during hypopneas. Overall Message: The APAP algorithm in prisma-devices show optimal suppression of respiratory events with adequate pressure regulation (therapy P50=7hPa). The majority of rare residual respiratory events was detected by prisma. Sleep quality increased independently from pressure level. Main Results: (1) Apneas were differentiated reliably, obstructions were treated effectively, the arousal index significantly decreased. (2) The APAP mode significantly increased REM and slow wave sleep; independently from therapy pressure level, thus improving sleep quality overall. Further Conclusion: • Five patients presented TECSA (treatment emergent central sleep apnoea) and were supposedly mainly suffering from central apneas coinciding with upper airway obstructions, they also showed significantly higher (mouth) leakage (associated with higher CO 2 washout) and pressure levels. These events were correctly detected by FOT, but pose challenges to adequate therapy. 2 3) It was proven that APAP pressure was only moderately increased to treat events effectively (Löwenstein philosophy in standard regulation). Method: • Inclusion: 46 patients with severe OSAS (AHI 36), mostly obese with routine PSG for suspected OSA • 43 patients with nasal mask. • prisma LAB in APAP standard mode, open pressure threshold from 5-20hPa, 15min softSTART. • 1 diagnosis night, 1 therapy night 1 Zhu K, Roisman G, Aouf S, Escourrou P (2015) All APAPs are not equivalent for the treatment of sleep disordered breathing: a bench evaluation of eleven commercially available devices. J Clin Sleep Med 11:725–734. https://doi.org/10.5664/jcsm.4844 2 Please refer to the therapy option of adjustable pressure limits (Pmax oA) in prisma- devices, also in detail described in the White Paper Edition by LMT “Central Respiratory Events during CPAP / EPAP Therapy ”

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