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Appendix 6
RESEARCH ARTICLE Novel Approach to Simulate Sleep Apnea Patients for Evaluating Positive Pressure Therapy Devices Valentina Isetta 1,2 , Josep M. Montserrat 2,3,4 , Raquel Santano 1 , Alison J. Wimms 5 , Dinesh Ramanan 5 , Holger Woehrle 5 , Daniel Navajas 1,2,6 , Ramon Farré 1,2,4 * 1 Unitat de Biofísica i Bioenginyeria, Facultat de Medicina, Universitat de Barcelona, Barcelona, Spain, 2 CIBERES, Madrid, Spain, 3 Sleep Laboratory, Pneumology Department, Hospital Clinic, Barcelona, Spain, 4 Institut d'Investigacions Biom è diques August Pi i Sunyer, IDIBAPS, Barcelona, Spain, 5 ResMed Science Centre, Munich, Germany, 6 Institute for Bioengineering of Catalonia, IBEC, Barcelona, Spain
* rfarre@ub.edu
Abstract Bench testing is a useful method to characterize the response of different automatic positive airway pressure (APAP) devices under well-controlled conditions. However, previous mod- els did not consider the diversity of obstructive sleep apnea (OSA) patients ’ characteristics and phenotypes. The objective of this proof-of-concept study was to design a new bench test for realistically simulating an OSA patient ’ s night, and to implement a one-night exam- ple of a typical female phenotype for comparing responses to several currently-available APAP devices. We developed a novel approach aimed at replicating a typical night of sleep which includes different disturbed breathing events, disease severities, sleep/wake phases, body postures and respiratory artefacts. The simulated female OSA patient example that we implemented included periods of wake, light sleep and deep sleep with positional changes and was connected to ten different APAP devices. Flow and pressure readings were recorded; each device was tested twice. The new approach for simulating female OSA patients effectively combined a wide variety of disturbed breathing patterns to mimic the response of a predefined patient type. There were marked differences in response between devices; only three were able to overcome flow limitation to normalize breathing, and only five devices were associated with a residual apnea-hypopnea index of < 5/h. In conclusion, bench tests can be designed to simulate specific patient characteristics, and typical stages of sleep, body position, and wake. Each APAP device behaved differently when exposed to this controlled model of a female OSA patient, and should lead to further understanding of OSA treatment.
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Citation: Isetta V, Montserrat JM, Santano R, Wimms AJ, Ramanan D, Woehrle H, et al. (2016) Novel Approach to Simulate Sleep Apnea Patients for Evaluating Positive Pressure Therapy Devices. PLoS ONE 11(3): e0151530. doi:10.1371/journal. pone.0151530
Editor: Gennady Cymbalyuk, Georgia State University, UNITED STATES
Received: September 23, 2015
Accepted: February 28, 2016
Published: March 15, 2016
Copyright: © 2016 Isetta et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability Statement: All relevant data are within the paper. Funding: The work presented here has been partially supported by a research agreement (number 307990) between ResMed Science Centre and Universitat de Barcelona (PI: Ramon Farré). The work has been also partially funded by Ministerio de Economía y Competitividad (PI14/0004). There was no additional funding received for this study. ResMed Science Centre provided support in the form of salaries for authors AJW, DR, and HW, but did not have any additional role in the study design, data
Introduction Obstructive sleep apnea (OSA) is a prevalent breathing disorder and is considered a major pub- lic health issue, affecting 5 – 15% of the general population and increasing with both body mass index and age (up to at least 60 – 65 years) [1,2]. OSA is characterized by repetitive narrowing
PLOS ONE | DOI:10.1371/journal.pone.0151530 March 15, 2016
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