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Open Access 25-04-2024 | Polysomnography | Sleep Breathing Physiology and Disorders • Original Article

Validation of self-applied unattended polysomnography using Somte V2 PSG (Somte) for diagnosis of obstructive sleep apnoea (OSA) in pregnant women in early to mid-gestation

Authors: Frances Clements, Angela Makris, Yewon Chung, Jonathon Poh, Nathaniel S. Marshall, Kerri Melehan, Renuka Shanmugalingam, Annemarie Hennessy, Hima Vedam

Published in: Sleep and Breathing

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Abstract

Purpose

Polysomnography (PSG) may be completed in the home environment (unattended), and when self-applied, allow the collection of data with minimal healthcare worker intervention. Self-applied, unattended PSG in the home environment using Somte PSG V2 (Somte) has not been validated in pregnant women in early to mid-gestation. We undertook a study to evaluate the accuracy of Somte compared to attended PSG. The agreement between apnoea hypopnea index (AHI) and respiratory disturbance index (RDI) scores in Somte and PSG in early to mid-gestation were assessed.

Methods

Pregnant women (≤ 24 weeks gestation) were scheduled for PSG and Somte within a 7-day window, in any order. Somte were self-applied and completed in the home. Somte were scored blinded to PSG result. AHI was the primary outcome of interest, though an AHI ≥ 5 or RDI ≥ 5 on PSG was considered diagnostic of Obstructive Sleep Apnoea (OSA). AHI, RDI, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) was calculated and receiver operating characteristic (ROC) curves were produced. Bland–Altman plots were used to determine agreement. Technical issues occurring during tests were explored.

Results

Twenty-four participants successfully completed both tests between March 2021 and January 2023. PSG were completed at around 14.1 weeks’ gestation (IQR 13.4, 15.7). The time interval between Somte and PSG was a median of 4 days (IQR 2, 7 (range 1–12)). Five (20.8%) women had OSA on PSG at AHI ≥ 5 and 10 (41.6%) women had OSA on PSG at RDI ≥ 5. Somte and PSG did not differ in the measurement of AHI ((1.8, 1.6, p = 0.09) or RDI (3.3, 3.5), p = 0.73).
At AHI ≥ 5, diagnostic test accuracy (area under the ROC curve) of Somte was 0.94, sensitivity 80.0%, specificity 94.7%, PPV and NPV were 80.0% and 94.7% respectively. At RDI ≥ 5, diagnostic test accuracy (area under the ROC curve) was 0.95, sensitivity 60.0%, specificity 93.0% and PPV and NPV were 85.7% and 76.4% respectively. The confidence limits of Bland–Altman plots were 6.37 to − 8.89 at cut off AHI ≥ 5 and 8.89 to − 10.43 at cut off RDI ≥ 5. Somte failed to start in four tests. Technical issues were reported in both Somte (n = 13, 54.2%) and PSG (n = 6, 25.0%).

Conclusion

Self-applied, unattended Somte may provide an acceptable substitute to attended PSG in the identification of OSA in pregnant women in early to mid-gestation in this small sample but may fail to detect cases of OSA, particularly when using RDI as the diagnostic marker.
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Metadata
Title
Validation of self-applied unattended polysomnography using Somte V2 PSG (Somte) for diagnosis of obstructive sleep apnoea (OSA) in pregnant women in early to mid-gestation
Authors
Frances Clements
Angela Makris
Yewon Chung
Jonathon Poh
Nathaniel S. Marshall
Kerri Melehan
Renuka Shanmugalingam
Annemarie Hennessy
Hima Vedam
Publication date
25-04-2024
Publisher
Springer International Publishing
Keyword
Polysomnography
Published in
Sleep and Breathing
Print ISSN: 1520-9512
Electronic ISSN: 1522-1709
DOI
https://doi.org/10.1007/s11325-024-03025-0
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