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A randomized controlled trial to validate the Alice PDX ambulatory device.
Georg Nilius1, Ulrike Domanski1, Maik Schroeder1
1HELIOS-Klinik Ambrock, Universität Witten-Herdecke, Hagen, Germany.
Nature and Science of Sleep
|June 28, 2017
Summary
The Alice PDX portable device accurately diagnosed obstructive sleep apnea (OSA) when compared to polysomnography (PSG). This validated portable monitoring device can reliably diagnose OSA at home.
Area of Science:
- Sleep Medicine
- Medical Devices
Background:
- Obstructive sleep apnea (OSA) is common but often undiagnosed.
- Sleep laboratories have potential to increase diagnostic capacity.
- This study validates a portable respiratory monitoring device (Alice PDX) against polysomnography (PSG).
Purpose of the Study:
- To validate the Alice PDX portable device against in-laboratory PSG.
- To assess the reliability of the Alice PDX for home diagnostic studies.
Main Methods:
- 85 patients with suspected OSA underwent 3 nights of diagnostic testing.
- Testing included simultaneous in-laboratory PSG and PDX recording, self-applied PDX at home, and in-laboratory PSG.
- Data were manually scored per American Academy of Sleep Medicine criteria.
Main Results:
- The Alice PDX showed 96.4% diagnostic agreement with simultaneous PSG.
- Minor over/underestimations of the apnea-hypopnea index (AHI) occurred in 2.4% and 1.2% of studies, respectively.
- Differences in AHI between reference PSG and home study were comparable to differences between PSGs.
Conclusions:
- The Alice PDX is a valid tool for home diagnostic studies of OSA.
- Manually scored, the portable device aids specialists in diagnosing moderate-to-severe OSA in high-probability cases.
- The technology is reliable for use outside traditional sleep laboratory settings.
