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. 2021 Apr 16;16(4):e0249470.
doi: 10.1371/journal.pone.0249470. eCollection 2021.

Validation of a new wearable device for type 3 sleep test without flowmeter

Mauro Contini  1 , Antonio Sarmento  2 , Paola Gugliandolo  1 , Alessandra Leonardi  3 , Gianluigi Longinotti-Buitoni  3 , Camilla Minella  4 , Carlo Vignati  1   5 , Massimo Mapelli  1 , Andrea Aliverti  2 , Piergiuseppe Agostoni  1   5
Affiliations

Validation of a new wearable device for type 3 sleep test without flowmeter

Mauro Contini et al. PLoS One. .

Abstract

Background: Ventilation monitoring during sleep is performed by sleep test instrumentation that is uncomfortable for the patients due to the presence of the flowmeter. The objective of this study was to evaluate if an innovative type 3 wearable system, the X10X and X10Y, is able to correctly detect events of apnea and hypopnea and to classify the severity of sleep apnea without the use of a flowmeter.

Methods: 40 patients with sleep disordered breathing were analyzed by continuous and simultaneous recording of X10X and X10Y and another certified type 3 system, SOMNOtouch, used for comparison. Evaluation was performed in terms of quality of respiratory signals (scores from 1, lowest, to 5, highest), duration and classification of apneas, as well as identification and duration of hypopneas.

Results: 580 periods were evaluated. Mean quality assigned score was 3.37±1.42 and 3.25±1.35 for X10X and X10Y and SOMNOtouch, respectively. The agreement between the two systems was evaluated with grades 4 and 5 in 383 out of 580 cases. A high correlation (r2 = 0.921; p<0.001) was found between the AHI indexes obtained from the two systems. X10X and X10Y devices were able to correctly classify 72.3% of the obstructive apneas, 81% of the central apneas, 61.3% of the hypopneas, and 64.6% of the mixed apneas when compared to SOMNOtouch device.

Conclusion: The X10X and X10Y devices are able to provide a correct grading of sleep respiratory disorders without the need of a nasal cannula for respiratory flow measurement and can be considered as a type 3 sleep test device for screening tests.

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Conflict of interest statement

Dr. Longinotti-Buitoni and Dr. Aliverti are inventors in patents related to the submitted work (Patents number US20200323285, US20200068708, US20180376586, US20180184735, US9282893). Dr. Aliverti received consultancy fees from L.I.F.E. Corporation S.A. outside the submitted work. Dr. Agostoni has non-financial support from Menarini, grants from Daiichi Sankyo, nonfinancial support from Novartis, non-financial support from Boeringer, grants and nonfinancial support from Actelion, and grants from Bayer, outside the work presented in this article. This does not alter the adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Schematic diagram of X10Y (version for male subjects: Two left images) and X10X (version for female subjects: Two images on the right) medical devices.
The garment embeds ten ink-based dry electrodes (red points) to provide 12 lead ECG and three respiratory strain sensors positioned circumferentially around the body at thoracic level (level of the manubrium, TRX), xiphoid process level (XIP), and abdominal level (between the lower costal margin and the umbilical level, AB).
Fig 2
Fig 2. Representative example of signals measured during a hypopnea event in a patient (79 years, male, BMI = 23.3).
From top to bottom: flow (measured by SOMNOtouch device); sum signal (thoracic + abdominal) obtained from SOMNOtouch device; thoracic (blue) and abdominal (orange) signals from SOMNOtouch device; oxygen saturation from pulse oximeter; sum signal (thoracic +xiphoid + abdominal) obtained from X10X-Y device; thoracic (blue), xiphoid (orange) and abdominal (green) signals from X10X-Y device.
Fig 3
Fig 3. Representative example of signals measured during a central apnoea event in a patient (71 years, male, BMI = 26.2).
From top to bottom: flow (measured by SOMNOtouch device); sum signal (thoracic + abdominal) obtained from SOMNOtouch device; thoracic (blue) and abdominal (orange) signals from SOMNOtouch device; oxygen saturation from pulse oximeter; sum signal (thoracic +xiphoid + abdominal) obtained from X10X-Y device; thoracic (blue), xiphoid (orange) and abdominal (green) signals from X10X-Y device.
Fig 4
Fig 4. Representative example of signals measured during an obstructive sleep apnoea event in a patient (79 years, male, BMI = 23.3).
From top to bottom: flow (measured by SOMNOtouch device); sum signal (thoracic + abdominal) obtained from SOMNOtouch device; thoracic (blue) and abdominal (orange) signals from SOMNOtouch device; oxygen saturation from pulse oximeter; sum signal (thoracic +xiphoid + abdominal) obtained from X10X-Y device; thoracic (blue), xiphoid (orange) and abdominal (green) signals from X10X-Y device.
Fig 5
Fig 5. Representative example of signals measured during a mixed apnoea event in a patient (71 years, male, BMI = 26.2).
From top to bottom: flow (measured by SOMNOtouch device); sum signal (thoracic + abdominal) obtained from SOMNOtouch device; thoracic (blue) and abdominal (orange) signals from SOMNOtouch device; oxygen saturation from pulse oximeter; sum signal (thoracic +xiphoid + abdominal) obtained from X10X-Y device; thoracic (blue), xiphoid (orange) and abdominal (green) signals from X10X-Y device.
Fig 6
Fig 6. Patient flow and apnea severity as assessed by X10X-Y and SOMNOtouch devices.
Fig 7
Fig 7
Left panel: Correlation between apnea hypopnea index (AHI) observed with X10X and X10Y and SOMNOtouch™ RESP devices. Squares represent areas of agreement in the AHI severity classification. Right Panel: Bland-Altman plot of AHI detected by X10X and X10Y and SOMNOtouch™ RESP devices. Confidence intervals of bias and limits of agreement are shown.
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