TY - JOUR T1 - Registry on the treatment of central and complex sleep-disordered breathing with adaptive servo-ventilation (READ-ASV): protocol and cohort profile JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00618-2022 SP - 00618-2022 AU - Michael Arzt AU - Oliver Munt AU - Jean-Louis Pépin AU - Raphael Heinzer AU - Raphaela Kübeck AU - Ulrike von Hehn AU - Daniela Ehrsam-Tosi AU - Adam Benjafield AU - Holger Woehrle A2 - , Y1 - 2023/01/01 UR - http://openres.ersjournals.com/content/early/2023/01/05/23120541.00618-2022.abstract N2 - 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). 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 endpoint is change in disease-specific QoL (based on the Functional Outcomes of Sleep Questionnaire [FOSQ]) from baseline to 12-month follow-up. The registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (TE-CSA; 56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea (OSA) and CSA (OSA-CSA; 4%), OSA (3%), CSA in stroke (2%), and opioid-induced CSA (1%). Baseline mean apnoea-hypopnoea index was 48±23/h (≥30/h 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). In summary, the most common indications for ASV were TE-CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe SDB 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.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: MA has received grant support from ResMed, the ResMed Foundation, Philips Respironics and the Else-Kroehner Fresenisus Foundation. MA has received lecture and consulting fees from ResMed, Philips Respironics, Boehringer Ingelheim, NRI, Novartis and Jazz Pharmaceuticals outside the submitted work. JLP is supported by the French National Research Agency in the framework of the Investissements d'Avenir program [Grant ANR-15-IDEX-02] and the e-Health and Integrated Care and Trajectories Medicine and MIAI Artificial Intelligence (ANR-19- P3IA-0003) chairs of excellence from the Grenoble Alpes University Foundation. He reports lecture fees or conference traveling grants from ResMed, Philips, Jazz Pharmaceuticals, Agiradom, and Bioprojet. HW reports lecture/consulting fees from Astra Zeneca, Allergopharma, Bioprojet, Boehringer Ingelheim, Chiesi, GSK, Novartis, Inspire, Jazz and ResMed, and research support from ResMed and Novartis. RK is an employee of The Clinical Research Institute that was funded by ResMed to support this study. OM, AB and DE-T are all employees of ResMed. RH has no conflicts of interest to disclose. ER -