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

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

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.

Study Overview

• Status: Completed
• Conditions: Complex Sleep Apnea Syndrome; Chronic Heart Failure and; Obstructive Sleep Apnea Syndrome and; Idiopathic Central Sleep Apnea Syndrome; Idiopathic Induced Periodic Breathing; Central Sleep Apnea Syndrome
• Intervention / Treatment: Device: Adaptive Servo-Ventilation

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.

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Boujan sur Libron, France, 34480
    • Polyclinic Saint-Privat
  • Dijon, France, 21079
    • CHU Dijon
  • Marseille, France, 13015
    • Hopital Nord
  • Montpellier, France, 34295
    • Arnaud de Villeneuve University Hospital
  • Paris, France, 75651
    • Hôpital Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Dany JAFFUEL, MD, PhD, Polyclinic Saint-Privat

Publications and helpful links

General Publications

• Jaffuel D, Philippe C, Rabec C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions. Respir Res. 2019 Oct 29;20(1):235. doi: 10.1186/s12931-019-1221-9.
• Jaffuel D, Rabec C, Philippe C, Mallet JP, Georges M, Redolfi S, Palot A, Suehs CM, Nogue E, Molinari N, Bourdin A. Patterns of adaptive servo-ventilation settings in a real-life multicenter study: pay attention to volume! : Adaptive servo-ventilation settings in real-life conditions. Respir Res. 2020 Sep 21;21(1):243. doi: 10.1186/s12931-020-01509-7.
• Jaffuel D, Mallet JP, Combes N, Palot A, Rabec C, Molinari N, Jaber S, Bourdin A. [Adaptive servo-ventilation after the SERVE-HF study: The swan song?]. Rev Mal Respir. 2016 Sep;33(7):641-4. doi: 10.1016/j.rmr.2016.04.001. Epub 2016 May 5. No abstract available. French.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2015
• Primary Completion (Actual): January 17, 2017
• Study Completion (Actual): January 17, 2017

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (Estimate): April 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 25, 2020
• Last Update Submitted That Met QC Criteria: September 24, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Chronic Heart Failure; Adaptive Servo-Ventilation; Periodic Breathing; Central Sleep Apnea Syndrome; Central and Obstructive Sleep Apnea Syndrome; Complex Sleep Apnea Syndrome; Hunter-Cheyne-Stokes Breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Heart Failure; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Respiratory Aspiration; Apnea; Sleep Apnea, Central
• Other Study ID Numbers: 9498; 2014-A01565-42 (Other Identifier: RCB number)