Clinical Benefits & The Löwenstein Difference


obstructions results in lengthy periods of subtherapeutic pressures. The pressure regulation in Prisma20A (Auto) is therapeutically effective without unnecessary fluctuation*, whereby treatment is likely to be comfortable & well-balanced. Given the pleasant nature of the pressure regulation, it could be expected that the treatment dynamic offers benefits of both CPAP & APAP. Overall pressure graph appears gradual, gentle & consistent.** *Refer to Appendix 4 & 5, supported by Appendix 7 **Refer to Appendix 6, page 5, graph F (SOMNObalance e) & graph G (Prisma20A) Efficiency of Pressure The Löwenstein philosophy is to provide a pressure regulation that strives for the most efficient pressures possible. Results show low AHI/events (less than 5 AHI/hr) with little difference between the Pmean & Pmax pressure, with both figures relatively low.*

maintained no events, with measured mean pressures respectively 1.1 cmH2O & 0.8 cmH2O lower than the conventional required CPAP pressure. The only other pressure-relief feature tested which maintained no events measured mean pressure at just 0.2 cmH2O less than the conventional required CPAP pressure. By leaving no events & lowering mean pressure, it can be deduced that the timing of Löwenstein SoftPAP settings provide considerable pressure relief on exhalation without clinical impairment.

*Refer to Appendix 9, Page 3, Table 2

Conclusion Evidence suggests Löwenstein devices exhibit proactive, efficient & stable pressure adjustments when treating sleep disordered breathing. This gives insight into why many Löwenstein users experience benefits to their sleep & health, including: less arousals from pressure & leakage independent of AHI events, lower blood pressure, less thoracic demand, more natural breathing, greater sleep quality (i.e. more deep sleep), less hours of sleep, & greater PAP compliance (prerequisite to improving outcome of therapy). These results reportedly carry over to quality of life, i.e. feeling fresh, energetic & motivated. From a clinical standpoint, the accuracy of AHI, understanding of the structured algorithm response, option for 2 algorithm settings, extensive clinical data with epoch-based categorisation, & deep sleep indicator via respiratory minute volume provide extensive & varied information for professionals to optimise the treatment outcome for their patients. Lastly, the option of adding suitably timed pressure relief ‘SoftPaP’ settings during treatment adds another dimension to patient comfort without any evidence of clinical impact.

*Refer to Appendix 6, page 6, Device F (SOMNObalance e) & Device G (Prisma20A), & Appendix 8, page 3, APAP Device E (Somnobalance).

Pressure relief SoftPAP Löwenstein devices all come with options for SoftPAP expiration relief 1 (mild relief) & 2 (moderate relief). Additionally, Prisma20A/C has a softPAP 3 option which provides moderate relief as well as pressure support slightly above set pressure at the beginning of the inspiration phase, this provides effective comfort to the overall breathing process & feelings of shortness of breath. SoftPAP demonstrates minimal clinical impact to AHI index according to a respiratory bench model evaluation of pressure-relief features*. By manually titrating devices to the exact point of fixed pressure at which the respiratory model simulated AHI of 60/h was normalised to residual AHI of 0/h (no events), & then applying pressure relief features, the clinical impact of adding these features could be assessed. Out of 6 different pressure- relief features tested, 3 were able to maintain no events, whereas the other 3 resulted in residual AHI returning to 60/h. Löwenstein SoftPAP 2 & 3 were tested, both of which

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