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Impact of a multimodal telemonitoring intervention on CPAP adherence in symptomatic OSA and low cardiovascular risk: a randomized controlled trial
Tamisier R, Treptow E, Joyeux-Faure M, Levy P, Sapene M, Benmerad M, Bailly S, Grillet Y, Stach B, Muir J-F, Pegliasco H, Pepin J-L, on behalf of the OPTISAS Trial Investigators
Chest 2020 Nov;158(5):2136-2145
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: One of the major challenges in treating OSA is to achieve adequate CPAP adherence. Telemonitoring has the potential to provide individualized management and early recognition of problems during treatment. RESEARCH QUESTION: What is the effect of a multimodal telemonitoring intervention on treatment adherence, quality of life, and functional status in symptomatic patients with OSA and low cardiovascular risk? STUDY DESIGN AND METHODS: In a multicenter, randomized controlled trial, patients newly diagnosed with OSA were randomly assigned to multimodal telemonitoring for 6 months versus usual care (UC). Telemonitoring consisted of built-in electronic alert algorithms for early adjustment of CPAP treatment in case of side effects, leaks, or persistent residual events. The primary outcome was CPAP adherence (in hours per night). Secondary outcomes included daily symptoms such as fatigue and sleepiness, and quality of life measured by using self-reported questionnaires. RESULTS: A total of 206 patients with OSA and a median age of 50.6 years (interquartile range (IQR) 42.1 to 58.1 years) were included in the study; they were predominantly male (63%) with a median BMI of 30.6 kg/m2 (IQR 26.8 to 35.1 kg/m2) and a median apnea-hypopnea index of 45.2 events/h (IQR 34.0 to 60.0 events/h). Of these, 102 received UC and 104 received telemonitoring. After 6 months of treatment, CPAP adherence was similar in the two groups when assessed either by mean duration of usage (4.73 +/- 2.48 h per night in the telemonitoring group and 5.08 +/- 2.44 h per night in the UC group; p = 0.30) or in percentage of patients adherent to treatment (> 4 h usage per night, > 70% nights; 64% in the telemonitoring group versus 72% in the UC group; p = 0.24). There was no significant difference between the groups in effect size of improvement in fatigue and sleepiness. INTERPRETATION: In patients with severe OSA and low cardiovascular risk, multimodal telemonitoring did not increase CPAP adherence. For both the telemonitoring and UC groups, similar improvements in daytime symptoms were achieved. TRIAL REGISTRY: ClinicalTrials.gov number NCT01796769; URL www.ClinicalTrials.gov.

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