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Validation of ApneaLink™ Plus for the diagnosis of sleep apnea

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Abstract

Purpose

The aim of this study is to evaluate the validation of ApneaLink™ Plus (ALP) based on a large number of subjects in a prospective design.

Method

We recommended enrolling of 200 consecutive patients who had been referred because of habitual snoring or witnessed apnea during sleep. If consent was obtained, patients underwent standard polysomnography (PSG) and ALP evaluation simultaneously at the hospital (ALPlab), and repeated ALP at home (ALPhome) within 1 month. The parameters of ALP were scored based on three different systems, Manual, Auto AASM, and Auto scoring systems.

Result

Among the 200 patients who were recommended for enrollment, 149 completed the study. Sensitivity was good for all three scoring systems, while specificity was poor for the Auto scoring system. The area under curve was highest for the manual scoring system and lowest for the auto scoring system, and increased as the apnea-hypopnea index (AHI) cutoff value increased from 5 to 30. Regarding agreement with PSG, the manual scoring system was most superior, followed by the Auto AASM, and Auto scoring systems. The degree of agreement between PSG and ALP was affected by sleep efficiency and the arousal index. Moderate agreement between PSG and ALP based on central apnea index was observed.

Conclusion

ALP is an accurate and reliable device for the diagnosis of OSA. Manual scoring is recommended; however, Auto AASM is also acceptable. ALP detects central sleep apnea to a certain degree. Both sleep efficiency and the arousal index affect the results of ALP.

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Authors and Affiliations

  1. Department of Otorhinolaryngology-Head and Neck Surgery, College of Medicine, Konkuk University, Seoul, South Korea

    Jae Hoon Cho

  2. Department of Otolaryngology, School of Medicine, Ajou University, Woncheon-dong, Yeongtong-gu, Suwon, Gyeonggi-do, 443-721, South Korea

    Hyun Jun Kim

Authors
  1. Jae Hoon Cho
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  2. Hyun Jun Kim
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Corresponding author

Correspondence to Hyun Jun Kim.

Ethics declarations

Funding

This study was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (HC15C3415). The sponsor had no role in the design or conduct of this research.

Conflict of interest

All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge, or beliefs) in the subject matter or materials discussed in this manuscript.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

This was a prospective study conducted at the Ajou University Hospital and was approved by the internal review board (AJIRB-DEV-DE2-14-102) of the Ajou University Hospital and registered in the Clinical Research Information Service (KCT0002098). We received the written informed consent from all the patient who were enrolled to this study.

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Cho, J.H., Kim, H.J. Validation of ApneaLink™ Plus for the diagnosis of sleep apnea. Sleep Breath 21, 799–807 (2017). https://doi.org/10.1007/s11325-017-1532-3

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  • DOI: https://doi.org/10.1007/s11325-017-1532-3

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