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

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.

Conflict of interest statement

Conflict of interest: M. Arzt has received grant support from ResMed, the ResMed Foundation, Philips Respironics and the Else-Kroehner Fresenisus Foundation, and lecture and consulting fees from ResMed, Philips Respironics, Boehringer Ingelheim, NRI, Novartis and Jazz Pharmaceuticals outside the submitted work. O. Munt, D. Ehrsam-Tosi and A. Benjafield are all employees of ResMed. J-L. Pépin is supported by the French National Research Agency in the framework of the Investissements d'Avenir programme (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, and reports lecture fees or conference travel grants from ResMed, Philips, Jazz Pharmaceuticals, Agiradom and Bioprojet. R. Heinzer has no conflicts of interest to disclose. R. Kübeck is an employee of The Clinical Research Institute, which was funded by ResMed to support this study. H. Woehrle 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.

Copyright ©The authors 2023.

Figures

FIGURE 1

Schematic classification of indications for adaptive servo-ventilation (ASV) therapy as defined during expert review board classification. Teal boxes represent diagnostic findings (e.g. diagnostic polysomnography or polygraphy or, if these were not available, based on the aetiology provided by the investigator) and blue boxes represent findings during standard positive airway pressure (PAP) therapy but also take into account the reason for a switch to ASV therapy provided by the investigator. OSA: obstructive sleep apnoea; CSA: central sleep apnoea; CAI: central apnoea index; OAI: obstructive apnoea index; HI: hypopnoea index; CSR: Cheyne–Stokes respiration; HF: heart failure; CAD: coronary artery disease; AF: atrial fibrillation; TE-CSA: treatment-emergent or persistent central sleep apnoea; CVD: cardiovascular disease. #: depending on diagnostic information.

FIGURE 2

Indication for adaptive servo-ventilation therapy. TE-CSA: treatment-emergent or persistent central sleep apnoea; CSA: central sleep apnoea; CVD: cardiovascular disease; OSA: obstructive sleep apnoea.

FIGURE 3

Proportion of patients in the total population and by indication subgroup that was symptomatic based on a) a Functional Outcomes of Sleep Questionnaire (FOSQ) score 10 (n=246 of 720) and c) an FOSQ score 10 (n=456 of 736). The numbers and circles at the bottom of the columns indicate the size of the respective subgroup. TE-CSA: treatment-emergent or persistent central sleep apnoea; CSA: central sleep apnoea; CVD: cardiovascular disease; OSA: obstructive sleep apnoea.