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

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

doi:10.1007/s11325-024-02994-6

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

Sleep Breath. 2024 Jan 16. doi: 10.1007/s11325-024-02994-6. Online ahead of print.

Authors

Liyue Xu^#¹, Huijie Yi^#^{1

2}, Mengyuan Pi¹, Chi Zhang¹, Brendan T Keenan³, Henry A Glick⁴, Xiaosong Dong¹, Allan I Pack³, Fang Han⁵, Samuel T Kuna⁶

Affiliations

¹ Department of Sleep Medicine, Peking University People's Hospital, No. 11, South Avenue, Beijing, China.
² Nursing School, Peking University, Beijing, China.
³ Division of Sleep Medicine, Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, USA.
⁴ Division of General Internal Medicine, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
⁵ Department of Sleep Medicine, Peking University People's Hospital, No. 11, South Avenue, Beijing, China. hanfang1@hotmail.com.
⁶ Department of Medicine, Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.

^# Contributed equally.

PMID: 38225441
DOI: 10.1007/s11325-024-02994-6

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.

Keywords: Cost-effectiveness; Home sleep apnea test; Non-inferior analysis; Obstructive sleep apnea; Telemedicine.

Abstract

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