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Validation of the Apnealink Air for diagnosis of obstructive sleep apnoea (OSA) in pregnant women in early-mid gestation

  • Sleep Breathing Physiology and Disorders • Original Article
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Abstract

Purpose

The detection of obstructive sleep apnoea (OSA) in pregnant women in early-mid gestation is logistically difficult. Accurate alternates to polysomnography (PSG) in early pregnancy are not well identified. We compared the agreement between Apnealink Air (AL) and existing screening questionnaires to PSG in pregnant women ≤ 24-week gestation.

Methods

Pregnant women (≤ 24-week gestation) underwent AL at home plus attended PSG in any order, completed within 7 days where practicable. AL was manually scored (AL(M)) and automatically scored (AL(A)). An apnoea-hypopnea index (AHI) ≥ 5 was considered diagnostic of OSA and an AHI ≥ 15 considered at least moderate OSA. Diagnostic analysis was undertaken (sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV)) by generating receiver operating characteristic (ROC) curves and an area under the curve (AUC) (95% CI). Bland–Altman plots were used to plot agreement. Screening questionnaires (Epworth sleepiness score (ESS), STOP-BANG, calculated pregnancy-specific screening tool) were compared to PSG.

Results

A total of 49 participants successfully completed both tests at around 14-weeks gestation (IQR 12.9, 17.1). The time interval between AL and PSG was a median of 2 days (IQR 1, 5 (range 1–11)). A total of 14 (29%) participants had OSA. The median AHI of AL(A) (3.1(IQR 0.85,4.6)) and AL(M) (IQR2.4(0.65,4.8)) did not differ from PSG (1.7(IQR1.0,6.1)). AL(A) and AL(M) compared to PSG demonstrated diagnostic test accuracy (area under curve (ROC)) of 0.94(95% CI 0.87–1.0) and 0.92(95% CI 0.85–1.0) respectively. Apnealink Air outperformed screening questionnaires tested.

Conclusion

The findings suggest that Apnealink may provide a substitute to attended PSG identification of OSA in pregnant women in early-mid gestation using both manual and auto-scoring methods.

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Data availability

Data will be made available on reasonable request.

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Acknowledgements

We would like to thank the participants of this study for their time, Liverpool Hospital sleep unit staff for their assistance and Wendy Xu for scoring all sleep studies. We wish to thank research midwives Alison Canty, Gaksoo Lee and Wendy Pickup for their assistance with participant recruitment.

Funding

Hima Vedam has received an equipment grant from Women’s Health Translational Academic Unit (WHITU) and seed grant from Respiratory, Sleep, Environmental and Occupational Health (RSEOH) Clinical Academic Group (CAG) of Maridulu Budyari Gumal (Sydney Partnership for Health, Education, Research and Enterprise, SPHERE). Frances Clements has received RSEOH CAG PhD Support Grant and School of Medicine Postgraduate Research Scholarship from WHITU and Western Sydney University. Polysomnography, and Apnealink devices used in the study were supplied by the sleep investigations unit at Liverpool Hospital.

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Authors and Affiliations

  1. Department of Respiratory and Sleep Medicine, Liverpool Hospital, South Western Sydney Local Health District, Liverpool, New South Wales, Australia

    Frances Clements, Yewon Chung & Hima Vedam

  2. School of Medicine, Western Sydney University, Campbelltown, New South Wales, Australia

    Frances Clements, Angela Makris, Renuka Shanmugalingam & Annemarie Hennessy

  3. Women’s Health Initiative Translational Unit, Ingham Institute for Medical Research, South Western Sydney Local Health District, Sydney, New South Wales, Australia

    Frances Clements, Angela Makris, Yewon Chung, Renuka Shanmugalingam, Annemarie Hennessy & Hima Vedam

  4. School of Clinical Medicine, South Western Sydney Clinical Campuses, Discipline of Medicine, UNSW Sydney, Sydney, New South Wales, Australia

    Angela Makris, Yewon Chung, Renuka Shanmugalingam & Hima Vedam

  5. Woolcock Institute of Medical Research, Centre for Sleep and Chronobiology, Macquarie University, Sydney, New South Wales, Australia

    Nathaniel S. Marshall

  6. Department of Health Sciences, Macquarie University, Macquarie Park, Australia

    Nathaniel S. Marshall

  7. Faculty of Medicine and Health, University of Sydney, Sydney, Australia

    Kerri Melehan

  8. Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

    Kerri Melehan

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  1. Frances Clements
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Contributions

HV was investigator with overall responsibility for this study. YC and FC designed REDcap database. YC and HV reported all studies. FC collected and entered all data into REDcap. FC and AM interpreted and analysed data. FC drafted manuscript. NM assisted with statistical analysis and interpretation. All authors have read, contributed to and approved the final manuscript.

Corresponding author

Correspondence to Frances Clements.

Ethics declarations

Ethics approval

This study was approved by SWSLHD human research and ethics committee on June 12th, 2019 (Project identifier 2019/ETH00283). The current protocol version 3.1 was approved on 11th Nov 2022. Informed consent was obtained from all participants.

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The images in Figs. 1a and b depict the manuscript’s author and were taken and published with written permission.

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The authors declare no competing interests.

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Clements, F., Makris, A., Chung, Y. et al. Validation of the Apnealink Air for diagnosis of obstructive sleep apnoea (OSA) in pregnant women in early-mid gestation. Sleep Breath 28, 1207–1216 (2024). https://doi.org/10.1007/s11325-023-02975-1

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