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16-01-2024 | Telemedicine | Sleep Breathing Physiology and Disorders • Original Article

Telemedicine management of obstructive sleep apnea disorder in China: a randomized, controlled, non-inferiority trial

Authors: Liyue Xu, Huijie Yi, Mengyuan Pi, Chi Zhang, Brendan T. Keenan, Henry A. Glick, Xiaosong Dong, Allan I. Pack, Fang Han, Samuel T. Kuna

Published in: Sleep and Breathing | Issue 3/2024

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Abstract

Purpose

Previous studies assessed different components of telemedicine management pathway for OSA instead of the whole pathway. This randomized, controlled, and non-inferiority trial aimed to assess whether telemedicine management is clinically inferior to in-person care in China.

Methods

Adults suspected of OSA were randomized to telemedicine (web-based questionnaires, self-administered home sleep apnea test [HSAT], automatically adjusting positive airway pressure [APAP], and video-conference visits) or in-person management (paper questionnaires, in-person HSAT set-up, APAP, and face-to-face visits). Participants with an apnea–hypopnea index (AHI) ≥ 15 events/hour received APAP for 3 months. The non-inferiority analysis was based on the change in Functional Outcomes of Sleep Questionnaire (FOSQ) score and APAP adherence. Cost-effectiveness analysis was performed.

Results

In the modified intent-to-treat analysis set (n = 111 telemedicine, 111 in-person), FOSQ scores improved 1.73 (95% confidence interval [CI], 1.31–2.14) points with telemedicine and 2.05 (1.64–2.46) points with in-person care. The lower bound of the one-sided 95% non-inferiority CI for the difference in change between groups of − 0.812 was larger than the non-inferiority threshold of − 1. APAP adherence at 3 months was 243.3 (223.1–263.5) minutes/night for telemedicine and 241.6 (221.3–261.8) minutes/night for in-person care. The lower bound of the one-sided 95% non-inferiority CI of − 22.2 min/night was higher than the non-inferiority delta of − 45 min/night. Telemedicine had lower total costs than in-person management (CNY 1482.7 ± 377.2 vs. 1912.6 ± 681.3; p < 0.0001), driven by patient costs, but no significant difference in QALYs.

Conclusions

Functional outcomes and adherence were not clinically inferior in patients managed by a comprehensive telemedicine approach compared to those receiving in-person care in China.

Clinical trial registration

https://​www.​chictr.​org.​cn, Registration number ChiCTR2000030546. Retrospectively registered on March 06, 2020.
Appendix
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Metadata
Title
Telemedicine management of obstructive sleep apnea disorder in China: a randomized, controlled, non-inferiority trial
Authors
Liyue Xu
Huijie Yi
Mengyuan Pi
Chi Zhang
Brendan T. Keenan
Henry A. Glick
Xiaosong Dong
Allan I. Pack
Fang Han
Samuel T. Kuna
Publication date
16-01-2024
Publisher
Springer International Publishing
Published in
Sleep and Breathing / Issue 3/2024
Print ISSN: 1520-9512
Electronic ISSN: 1522-1709
DOI
https://doi.org/10.1007/s11325-024-02994-6

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