Telemedicine management of obstructive sleep apnea disorder in China: a randomized, controlled, non-inferiority trial.
Sleep Breath
; 28(3): 1173-1185, 2024 Jun.
Article
in En
| MEDLINE
| ID: mdl-38225441
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Telemedicine
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Sleep Apnea, Obstructive
Type of study:
Clinical_trials
/
Qualitative_research
Limits:
Adult
/
Aged
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Female
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Humans
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Male
/
Middle aged
Country/Region as subject:
Asia
Language:
En
Journal:
Sleep Breath
Journal subject:
NEUROLOGIA
/
OTORRINOLARINGOLOGIA
Year:
2024
Document type:
Article
Affiliation country:
Country of publication: