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

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.