Rationale: Continuous positive airway pressure (CPAP) is the standard treatment for the obstructive sleep apnea syndrome (OSAS), but long-term adherence remains a challenge. In a pilot study, we observed that telemedicine combined with telemetrically triggered interventions was associated with improved CPAP adherence in the first month of treatment. Objectives: In the current randomized, controlled phase III trial, we aimed to collect pivotal data for the use of telemedicine in CPAP treatment of patients with OSAS. Methods:Symptomatic patients with OSAS were randomized to a telemedicine or control arm and initiated CPAP treatment. Phone calls were triggered in the telemedicine group during the first month of treatment upon either poor use or excessive mask leakage. Patients were followed for 6 months. Measures of CPAP use at 6 months were the main study endpoints. Results: Among 240 patients enrolled, 71 (30%) discontinued CPAP treatment over the course of the study. The primary outcome measure, the proportion of nights with CPAP use greater than 1 hour, was not statistically different in the telemedicine group (92.0%) versus the control group (88.2%) (P = 0.565). The daily hours of CPAP use at 6 months also did not differ significantly between the telemedicine group (5.6 h) and the control group (4.8 h) (P = 0.663). However, in a post hoc analysis, telemedicine led to increased device use in a subgroup of patients with a mild form of disease (5.6 h vs. 3.4 h; P = 0.026). The telemedicine-based intervention had a positive impact on sleep-related quality of life as measured with the Quebec Sleep Questionnaire (5.55 vs. 5.49 at 1 mo [P = 0.020]; 5.61 vs. 5.46 at 6 mo [P = 0.013]).Conclusions: A telemetrically triggered intervention in the first month of treatment did not improve CPAP use in the study population overall, but it had positive effects in patients with a mild form of OSAS and led to an improvement in sleep-related quality of life.Clinical trial registered with www.clinicaltrials.gov (NCT01715194).
RCT Entities:
Rationale: Continuous positive airway pressure (CPAP) is the standard treatment for the obstructive sleep apnea syndrome (OSAS), but long-term adherence remains a challenge. In a pilot study, we observed that telemedicine combined with telemetrically triggered interventions was associated with improved CPAP adherence in the first month of treatment. Objectives: In the current randomized, controlled phase III trial, we aimed to collect pivotal data for the use of telemedicine in CPAP treatment of patients with OSAS. Methods: Symptomatic patients with OSAS were randomized to a telemedicine or control arm and initiated CPAP treatment. Phone calls were triggered in the telemedicine group during the first month of treatment upon either poor use or excessive mask leakage. Patients were followed for 6 months. Measures of CPAP use at 6 months were the main study endpoints. Results: Among 240 patients enrolled, 71 (30%) discontinued CPAP treatment over the course of the study. The primary outcome measure, the proportion of nights with CPAP use greater than 1 hour, was not statistically different in the telemedicine group (92.0%) versus the control group (88.2%) (P = 0.565). The daily hours of CPAP use at 6 months also did not differ significantly between the telemedicine group (5.6 h) and the control group (4.8 h) (P = 0.663). However, in a post hoc analysis, telemedicine led to increased device use in a subgroup of patients with a mild form of disease (5.6 h vs. 3.4 h; P = 0.026). The telemedicine-based intervention had a positive impact on sleep-related quality of life as measured with the Quebec Sleep Questionnaire (5.55 vs. 5.49 at 1 mo [P = 0.020]; 5.61 vs. 5.46 at 6 mo [P = 0.013]).Conclusions: A telemetrically triggered intervention in the first month of treatment did not improve CPAP use in the study population overall, but it had positive effects in patients with a mild form of OSAS and led to an improvement in sleep-related quality of life.Clinical trial registered with www.clinicaltrials.gov (NCT01715194).
Authors: Benjamin Ka Seng Thong; Grace Xin Yun Loh; Jia Jan Lim; Christina Jia Liang Lee; Shu Ning Ting; Hong Peng Li; Qing Yun Li Journal: Front Med (Lausanne) Date: 2022-05-03