READ-ASV Registry - Phase II — READ-ASV  

Sleep Apnea Clinical Trial

Official title: Registry on the Treatment of Central and Complex Sleep Disordered Breathing With Adaptive Servo-Ventilation

Status Recruiting

Clinical Trial Summary

The READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient characteristics and to document adverse events related to therapy for a therapy safety analysis.

Clinical Trial Description

The pilot phase (NCT03032029) enrolled over 200 patients now being analyzed. After completion of the the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 700-1000 patients over a period of 5 years. The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur after the first 12 months of therapy use. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. Each patient will be included for a maximum of 15 months, whereas serious events will be tracked throughout the total duration of phase I and II of the registry. ;

Related Conditions & MeSH terms

• Apnea
• Respiratory Aspiration
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disorder
• Sleep Wake Disorders
• Sleep-disordered Breathing

• NCT number: NCT04331821
• Study type: Observational
• Source: ResMed
• Contact: Oliver Munt, PhD
• Phone: +49 162 9056360
• Email: oliver.munt@resmed.de
• Status: Recruiting
• Start date: May 1, 2019
• Completion date: July 31, 2021