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. 4-5

New OSA Patient Simulator for Testing PAP Devices

Table 1. Description of the patient simulation implemented in the bench test model. Stage Duration AHI

Features

Sleep onset

45 min

-

16 breaths/min V T 500 mL Random insertion of changes in breathing rate and V T , and swallowing

Non-REM cycle 1

60 min

15/h

Body position: side Apneas (0 – 5 cmH 2 O): event length 12 sec Hypopneas (5 – 7 cmH 2 O): event length 16 sec

Flow limitation (7 – 9 cmH 2 O) Normal breathing ( > 9 cmH 2 O)

REM cycle 1

15 min

30/h

Apneas (0 – 8 cmH 2 O): event length 18 sec Hypopneas (8 – 10 cmH 2 O): event length 16 sec

Flow limitation (10 – 12 cmH 2 O) Normal breathing ( > 12 cmH 2 O)

Non-REM cycle 2

45 min

15/h

Body position: side Apneas (0 – 5 cmH 2 O): event length 12 sec Hypopneas (5 – 7 cmH 2 O): event length 16 sec

Flow limitation (7 – 10 cmH 2 O) Normal breathing ( > 10 cmH 2 O)

REM cycle 2

25 min

30/h

Apneas (0 – 7 cmH 2 O): event length 18 sec Hypopneas (7 – 9 cmH 2 O): event length 16 sec

Flow limitation (9 – 11 cmH 2 O) Normal breathing ( > 11 cmH 2 O)

Non-REM cycle 3

30 min

15/h

Apneas (0 – 5 cmH 2 O): event length 18 sec Hypopneas (5 – 7 cmH 2 O): event length 16 sec

Flow limitation (7 – 10 cmH 2 O) Normal breathing ( > 10 cmH 2 O)

REM cycle 3

30 min

30/h

Body position: supine Apneas (0 – 9 cmH 2 O): event length 18 sec Hypopneas (9 – 11 cmH 2 O): event length 16 sec

Flow limitation (11 – 13 cmH 2 O) Normal breathing ( > 13 cmH 2 O)

Awake

5 min

-

Normal breathing

AHI: apnea-hypopnea index; REM: rapid eye movement; V T : tidal volume.

doi:10.1371/journal.pone.0151530.t001

Breathing normalization with a residual AHI < 5/h was only achieved with devices A, B and D; devices E, H, I and J were associated with more than five residual events per hour. Pressure changes of each device throughout the whole test are displayed in Fig 1. Considering the 45-minute wake period, there was significant variation in the behaviour of the different devices. Table 3 shows the pressure values reached by each tested device at the end of the simulated wake period. Device C did not increase the pressure during wake periods.

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

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