Effects of Adaptive Servo-Ventilation on Quality of Life: The READ-ASV Registry.

Rationale: Adaptive servo-ventilation (ASV) effectively treats sleep-disordered breathing, including central sleep apnea (CSA) and coexisting obstructive sleep apnea (OSA).Objectives: The prospective, multicenter European READ-ASV (Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation) registry investigated the effects of first-time ASV therapy on disease-specific quality of life (QoL).Methods: The registry enrolled adults with CSA with or without OSA who had ASV therapy prescribed between September 2017 and March 2021. The primary endpoint was change in disease-specific QoL (Functional Outcomes of Sleep Questionnaire [FOSQ]) score between baseline and 12-month follow-up. Sleepiness determined using the Epworth Sleepiness Scale (ESS) score was a key secondary outcome. For subgroup analysis, participants were classified as symptomatic (FOSQ score < 17.9 and/or ESS score > 10) or asymptomatic (FOSQ score ⩾ 17.9 and/or ESS score ⩽ 10).Results: A total of 801 individuals (age, 67 ± 12 yr; 14% female; body mass index, 31 ± 5 kg/m2; apnea-hypopnea index, 48 ± 22/h) were enrolled; analyses include those with paired baseline and follow-up data. After 12 ± 3 months on ASV, median (interquartile range) FOSQ score had increased significantly from baseline (+0.8 [-0.2 to 2.2]; P < 0.001; n = 499). This was due to a significantly increased FOSQ score in symptomatic participants (+1.69 [0.38 to 3.05]), with little change in asymptomatic individuals (+0.11 [-0.39 to 0.54]). The median ESS score also improved significantly from baseline during ASV (-2.0 [-5.0 to 0.0]; P < 0.001).Conclusions: ASV treatment of CSA with or without coexisting OSA was associated with improvements in disease-specific QoL and daytime sleepiness, especially in individuals with sleep-disordered breathing symptoms before therapy initiation. These improvements in patient-reported outcomes support the use of ASV in this population.

Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV): protocol and cohort profile.

Background: Although adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL). Methods: This report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up. Results: The registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea--hypopnoea index was 48±23 events·h-1 (≥30 events·h-1 in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10). Conclusion: The most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.