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

Study Overview
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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.

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.

Official Title
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Observational and Transversal Study of Patients Treated in Real LifeConditions With Adaptive Servo-Ventilation

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

Intervention / Treatment
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* Device: Adaptive Servo-Ventilation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ASV Arm<br>The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care. | Device: Adaptive Servo-Ventilation<br>* Adaptive Servo-Ventilation proceeds by continually measuring either minute ventilation or airflow and calculates a target ventilation to be applied as needed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%) | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The day of inclusion | 
| ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months) | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | 
| Type of device used nad history of device used (CPAP used before 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) | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | 
| Used or not of an auto-EPAP | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | 
| Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency) | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | 
| Type of mask used and historical use of mask | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | 
| Changes in AHI as compared to baseline | 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). | The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) | 
| Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available | 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). | The day of inclusion | 
| Changes in Asthenia by measuring Pichot scale as compared to baseline if available | 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). | The day of inclusion | 
| Number of hospitalization during the last year and etiology of the hospitalization | 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). | The day of inclusion | 
| Presence of a cardiomyopathy | 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). | The day of inclusion | 
| Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported) | 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). | The day of inclusion | 
| Number of patients not showing up for the annual consultation | 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). | One year after the start of the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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