Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation (READ-ASV)

ResMed

Status: Completed

Conditions: Mixed Sleep Apnea; Central Sleep Apnea; Complex Sleep Apnea; Obstructive Sleep Apnea

Treatments: Device: Adaptive Servo-Ventilation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03032029

Protocol 2019-04-16 (Other Identifier)

READ-ASV_Reg_Protoc_170404

Details and patient eligibility

About

Phase 1: The European 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. A pilot phase will enrol at least 200 patients to test the feasibility of the registry. After the pilot phase will be completed and an intermediate data analysis had been performed, the registry will be expanded over several countries across Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: 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.

Full description

Phase 1: 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 during the first 6 months. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. We recommend FU visit at least once year (after the first routine FU visit). Each patient will be included for 6 months, the total duration of phase 1 of the registry. Phase 2: The pilot phase 1 enrolled over 200 patients. After completion of the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 800 patients over a period of 4 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.

Enrollment: 847 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over ≥18 years of Age
• Prescription of ResMed AirCurve 10 CS PaceWave or S9 AutoSet CS PaceWave for treatment of ASV
• Naive to ASV Treatment
• Able to fully understand information on data protection and provide written informed consent

Exclusion criteria

• Heart Failure (HF) with a Left Ventricular Ejection Fraction (LVEF) <45% and CSA >50% central apneas of all apneas

Phase 2: Inclusion Criteria:

• ≥ 18 years old.
• Indication for treatment with ASV according to applicable medical guidelines.
• Use of eligible ResMed devices for treatment with ASV according to the Instructions For Use of the corresponding device.
• Naive to ASV treatment (max. 7 days between start of ASV therapy and enrolment).
• Able to fully understand information on data protection and provide written informed consent for use of their medical data.

Phase 2: Exclusion Criteria:

• Chronic, symptomatic heart failure (NYHA 2-4) with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central sleep apnea.