Adaptive Servo-Ventilation in "Real Life" Conditions : the OTRLASV Study

University Hospital Center (CHU)

Status: Completed

Conditions: Central Sleep Apnea Syndrome; Idiopathic Induced Periodic Breathing; Idiopathic Central Sleep Apnea Syndrome; Obstructive Sleep Apnea Syndrome and; Complex Sleep Apnea Syndrome; Chronic Heart Failure and

Treatments: Device: Adaptive Servo-Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT02429986

2014-A01565-42 (Other Identifier)

9498

Details and patient eligibility

About

Adaptive Servo-Ventilation (ASV) treatment is routinely prescribed in France. In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the investigators aim to describe the clinical characteristics of patients treated with ASV and the associated device settings.

Full description

The purpose of this study is to evaluate in "real life conditions" the use of Adaptative Servo-Ventilation (ASV) treatment. ASV treatment is routinely prescribed in France in patients with various sleep disorders breathing (Chronic Heart Failure (CHF) and Central Sleep Apnea Syndrome (CSAS), CHF and central and obstructive sleep apnea (COSA), Obstructive Sleep Apnea Syndrome (OSAS) and complex sleep apnea syndrome (compSAS), idiopathic or drug induced periodic breathing.

In order to be reimbursed according to the French Social Security rules, the patient treated with an ASV needs to be examined each year. In this observational transversal single-visit study, the aim is to describe the clinical characteristics of patients treated with ASV and the associated device settings. The aim is to evaluate the safety and efficacy issues in real life conditions of the ASV prescription.Depending of the data, data are obtained after analysis of the six latest months data of the ASV device, after questioning the patient, after analysis of the polygraphy/oximetry (if prescribed by the doctor for the renewal consultation of the ASV care and reimbursement by the French Social Security). All the data are obtained during the annual consultation required by the French Social Security.

Enrollment: 214 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• Age more than 18 years (inclusive)
• Patient treated with ASV for at least one year,and eligible for care and for the reimbursement by the French Social Security rules.
• Patient presenting at the annual control consultation for the continuation of the ASV treatment according to the French Social Security rules.

Exclusion criteria

• Pregnancy, intention of being pregnant, breastfeeding.
• Inability to understand the nature and aims of the study or to communicate with the investigator
• Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
• No affiliation to the French social security
• Loss of personal capacity resulting in state protection
• Deprivation of liberty by judicial or administrative decision

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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214 participants in 1 patient group

ASV Arm

Other group

Description:

The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care.

Treatment:

Device: Adaptive Servo-Ventilation