Registry on the treatment of central and complex sleep disordered breathing with adaptive servo-ventilation – the READ-ASV registry

Abstract

Rationale Little is known about the effects of ASV on quality of life (QoL), compliance and benefits in different medical conditions. The READ-ASV registry is a multi-center, prospective study on patients with newly initiated ASV therapy. Methods: The registry is running in 5 European countries (28 centers) to investigate effects of ASV on QoL, sleep (questionnaires FOSQ, EQ5D, PSQI) and sleepiness (ESS). Patients and therapy indications are characterized by demographics, comorbidities and underlying sleep disorder. ASV daily usage, hospitalizations and deaths are recorded. Results: Of 180 enrolled patients 16% (28) were female. Patients were 67 (+/-11,4) years of age with a BMI of 32 kg/cm2 (+/-5,6). 34 had a history of heart failure (LVEF 40-49% = 2; =50% = 32). 17 were NYHA I, 21 were NYHA II, 6 were NYHA III. The patients exhibited diabetes (48), hypertension (143), coronary artery disease (39) and atrial fibrillation (59). 12 took sedatives, 25 opioids, 28 antidepressives, 95 ACE inhibitors, 94 beta blocker, 19 antiarrhythmics. 32% (46) had mild or moderate to severe daytime sleepiness at baseline (ESS score ?10). 24% had OSA, 25% had CSA and 40% had mixed SA (diagnostic AHI of 5-14 (7), 15-29 (24), =30 (19)). Questionnaire scores from baseline to follow-up will be compared to determine the effects of ASV therapy on QoL and health status, connected to usage patterns and patient characteristics. The registry will enrol 1000 patients in the EU and US