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

Primary Purpose

Chronic Heart Failure and, Complex Sleep Apnea Syndrome, Obstructive Sleep Apnea Syndrome and

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Adaptive Servo-Ventilation

About this trial

This is an interventional treatment trial for Chronic Heart Failure and focused on measuring Adaptive Servo-Ventilation, Chronic Heart Failure, Central Sleep Apnea Syndrome, Central and Obstructive Sleep Apnea Syndrome, Complex Sleep Apnea Syndrome, Hunter-Cheyne-Stokes Breathing, Periodic Breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Polyclinic Saint-Privat
CHU Dijon
Hôpital Nord
Arnaud de Villeneuve University Hospital
Hôpital Pitié Salpetrière

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ASV Arm

Arm 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.

Outcomes

Primary Outcome Measures

Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings

Relationship between the residual AHI and the associated pressure settings, in function of the phenotype of the patients (presence or absence of cardiopathy, presence or absence of altered left ventricular ejection fraction (≤45% or > 45%)

Secondary Outcome Measures

Sleep Disorder Breathing involved in the initial prescription of ASV

The data are obtained after questioning the patient (Epworth, Pichot and satisfaction scales) or after analysis of the six latest months data of the device or after analysis of the polygraphy/oximetry (if necessary and prescribed by the doctor in order to monitoring the patient for the renewal consultation of the ASV care and reimbursement by the French Social Security).

ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months)

Type of device used nad history of device used (CPAP used before ASV ?)

Used or not of an auto-EPAP

Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency)

Type of mask used and historical use of mask

Changes in AHI as compared to baseline

Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available

Changes in Asthenia by measuring Pichot scale as compared to baseline if available

Number of hospitalization during the last year and etiology of the hospitalization

Presence of a cardiomyopathy

Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported)

Number of patients not showing up for the annual consultation

Full Information

NCT ID

NCT02429986

First Posted

April 1, 2015

Last Updated

September 24, 2020

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT02429986

Brief Title

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

Acronym

OTRLASV

Official Title

Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

March 13, 2015 (Actual)

Primary Completion Date

January 17, 2017 (Actual)

Study Completion Date

January 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Adaptive Servo-Ventilation, Chronic Heart Failure, Central Sleep Apnea Syndrome, Central and Obstructive Sleep Apnea Syndrome, Complex Sleep Apnea Syndrome, Hunter-Cheyne-Stokes Breathing, Periodic Breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

214 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ASV Arm

Arm Type

Other

Arm 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.

Intervention Type

Device

Intervention Name(s)

Adaptive Servo-Ventilation

Intervention Description

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

Primary Outcome Measure Information:

Title

Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings

Description

Time Frame

The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. The measures are obtained after analysis of the six latest months data of the device.

Secondary Outcome Measure Information:

Title

Sleep Disorder Breathing involved in the initial prescription of ASV

Description

Time Frame

The day of inclusion

Title

ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months)

Description

Time Frame