A randomized controlled trial to validate the Alice PDX ambulatory device
Authors Nilius G, Domanski U, Schroeder M, Franke KJ, Hogrebe A, Margarit L, Stoica M, d'Ortho MP
Received 3 February 2017
Accepted for publication 19 April 2017
Published 6 June 2017 Volume 2017:9 Pages 171—180
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Colin Mak
Peer reviewer comments 2
Editor who approved publication: Professor Steven Shea
Georg Nilius,1 Ulrike Domanski,1 Maik Schroeder,1 Karl-Josef Franke,1 Anke Hogrebe,1 Laurent Margarit,2 Maria Stoica,2 Marie-Pia d’Ortho2,3
1HELIOS-Klinik Ambrock, Universität Witten-Herdecke, Hagen, Germany; 2Service de Physiologie – Explorations Fonctionnelles DHU FIRE, Groupe Hospitalier Bichat-Claude Bernard, Assistance Publique-Hopitaux de Paris, 3Université Denis Diderot Paris 7, Paris, France
Background: Obstructive sleep apnea (OSA) is a highly prevalent condition; however, the majority of patients remain undiagnosed. There is a potential to expand the diagnostic capacity of sleep laboratories. The study objective was to validate a portable respiratory monitoring device (Alice PDX) against polysomnography (PSG) in the laboratory and to assess its reliability at home.
Methods: A total of 85 patients with suspected OSA (80% male, mean age 49.1±13.5 years, body mass index 29.7±6.9 kg/m2, Epworth Sleepiness Scale 10.0±5.1) were randomized to 3 diagnostic nights: 1 night simultaneous in-laboratory PSG and PDX recording; 1 night self-applied PDX at home, and 1 night in-laboratory PSG. Study data were manually scored according to American Academy of Sleep Medicine criteria.
Results: The Alice PDX was in diagnostic agreement with simultaneously recorded reference PSG in 96.4% of studies. In 2.4% of studies the in-laboratory PDX underestimated and in 1.2% of studies it overestimated the apnea hypopnea index (AHI). The difference between the AHI from the reference PSG and the home study was similar to the difference between the PSGs (2.79 vs 0.79, p=0.08).
Conclusion: In a population with a high suspicion of OSA, the Alice PDX showed a high level of diagnostic agreement with a simultaneous PSG and performed valid home diagnostic studies for OSA. If manually scored, the portable device can be used by sleep specialists for diagnosing moderate-to-severe obstructive sleep apnea in cases with a high pretest probability for the disease over a wide range of disease severity. The technology can be deployed reliably outside of the sleep laboratory setting.
Keywords: sleep apnea, diagnostic, portable device, ambulant monitoring, polysomnography
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