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 6 Pgs. 6-7

New OSA Patient Simulator for Testing PAP Devices

Table 2. Reponses of automatic CPAP devices to a specific simulated OSA patient. Device P max , cmH 2 O P mean , cmH 2 O Residual AHI, /h Overcome obstructive events?

Overcome fl ow limitation?

Residual fl ow limitation, min (% sleep time)

A B C D E F G H

18.65

13.25

0.7 0.7

Yes Yes

Yes Yes

4 (2%) 4 (2%)

15.4 11.4 15.3

11.8 6.75 11.3

16.5

No

No

24 (12%)

0.6

Yes

Yes

24.5 (12%) 81 (40%) 167 (81%) 122 (60%) 76 (37%) 142 (69%) 132.5 (65%)

11.35

7.7 9.5

11.9

No

No No No No No No

12.6 12.1

2.4 1.6

Yes Yes

10.05

12.45

7.75

10

No

I

10.6 10.1

8.3 8.2

6.5 8.5

Yes

J

No

AHI: apnea-hypopnea index; P max : maximum positive airway pressure applied; P mean : mean positive airway pressure; A: AirSense 10 by ResMed; B: AirSense 10 AutoSet for Her by ResMed; C: Dreamstar by Sefam; D: Icon by Fisher & Paykel; E: Resmart by BMC; F: Somnobalance by Weinmann; G: Prisma 20A by Weinmann; H: System One by Respironics; I: iCH by Apex; J: XT-Auto by Apex.

doi:10.1371/journal.pone.0151530.t002

Three devices (A, B and E) displayed only mild pressure increases ( < 2 cmH 2 O). Moderate pressure increases (2.5 – 3 cmH 2 O) were displayed by three devices (H, I and J), and significant pressure increases ( > 7 cmH 2 O) were seen from three devices (D, F and G). Three examples of different responses during the simulated wake period are presented in Fig 2, together with the flow signal generated by the simulator during the initial awake phase, which consisted of nor- mal breathing with some events inserted simulating flow alterations due to irregular breathing (E) and swallowing (S). Devices A, B and D contain algorithms aimed at automatically detect- ing sleep onset (for A, B AutoRamp mode and for D SenseAwake mode). Devices A and B showed similar pressure increases with AutoRamp mode turned off, while device D responded with higher pressure increases when the SenseAwake mode turned off. To assess whether the observed variations in pressure during wake had an influence on the results of testing, a subset of devices that showed a moderate to significant pressure increase during sleep onset (D, G, H and I) were retested without the wake phase of the test. In this

Table 3. Pressure values reached by each device after 45 minutes of simulated wake. Device

APAP pressure after 45 min of simulated wake (cmH 2 O)

A B C D E F G H

5.4 (5.8 with AutoRamp OFF) 4.8 (5.2 with AutoRamp OFF)

4.0

11.2 (14.5 with SenseAwake OFF)

4.6

11.8 11.7

6.5 6.8 6.9

I

J

A: AirSense 10 by ResMed; B: AirSense 10 AutoSet for Her by ResMed; C: Dreamstar by Sefam; D: Icon by Fisher & Paykel; E: Resmart by BMC; F: Somnobalance by Weinmann; G: Prisma 20A by Weinmann; H: System One by Respironics; I: iCH by Apex; J: XT-Auto by Apex.

doi:10.1371/journal.pone.0151530.t003

PLOS ONE | DOI:10.1371/journal.pone.0151530 March 15, 2016

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