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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-13

Study Completion Date

2017-01-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASV Arm

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

Group Type OTHER

Adaptive Servo-Ventilation

Intervention Type DEVICE

Adaptive Servo-Ventilation proceeds by continually measuring either minute ventilation or airflow and calculates a target ventilation to be applied as needed.

Interventions

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Adaptive Servo-Ventilation

Adaptive Servo-Ventilation proceeds by continually measuring either minute ventilation or airflow and calculates a target ventilation to be applied as needed.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No