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

Michael Arzt; Oliver Munt; Jean-Louis Pépin; Raphael Heinzer; Raphaela Kübeck; Ulrike von Hehn; Daniela Ehrsam-Tosi; Adam Benjafield; Holger Woehrle

doi:10.1183/23120541.00618-2022

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

ERJ Open Res. 2023 Apr 17;9(2):00618-2022. doi: 10.1183/23120541.00618-2022. eCollection 2023 Mar.

Authors

Michael Arzt¹, Oliver Munt², Jean-Louis Pépin³, Raphael Heinzer⁴, Raphaela Kübeck⁵, Ulrike von Hehn⁶, Daniela Ehrsam-Tosi⁷, Adam Benjafield⁸, Holger Woehrle⁹

Affiliations

¹ Department of Internal Medicine II, University Hospital Regensburg, Regensburg, Germany.
² ResMed Science Centre, Martinsried, Germany.
³ Université Grenoble Alpes, Laboratoire HP2, U1300 Inserm, CHU Grenoble Alpes, Grenoble, France.
⁴ Centre d'Investigation et de Recherche sur le Sommeil, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
⁵ The Clinical Research Institute, Munich, Germany.
⁶ medistat GmbH, Krummwisch, Germany.
⁷ ResMed Science Centre, Basil, Switzerland.
⁸ ResMed Science Center, Sydney, NSW, Australia.
⁹ Sleep and Ventilation Center Blaubeuren, Ulm, Germany.

Abstract

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.