ResMed Inc. (ResMed), a company developing products for respiratory disorders, especially sleep-disordered breathing, is planning to complete Serve-HF trial for AutoSet CS 2 by December 2013. The aim of the study is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic dysfunction, already receiving optimal medical therapy, who have sleep disordered breathing (SDB) that is predominantly central sleep apnea.
The phase III, randomized, open label, parallel assignment, efficacy study is currently recruiting approximately 1260 participants. The principal investigators of the study are Helmut Teschler, Prof. Universitatsklinikum Essen, Martin Cowie, Prof. National Heart and Lung Institute (NHLI) Brompton Hospital, London.
The AutoSet CS 2 is an intuitive ventilator that monitors breathing constantly throughout the night. In a process known as adaptive servo-ventilation, it takes into consideration breathing rate and the amount of air inhaled and exhaled. When the device detects any changes in either of these factors, it helps maintain normal breathing. It monitors patient’s individual breathing patterns and continually adjusts to changes in a patient’s airway so that they always receive the lowest pressure necessary to keep their airway open throughout the night, improving comfort and overall compliance. It combines AutoSet algorithm with the whisper-quiet operation and smooth, natural waveform of new and improved EPR (expiratory pressure relief).
The official title of the study is “Treatment of Sleep-Disordered Breathing With Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure.”