Adaptive Servo-Ventilation in "Real Life" Conditions : the OTRLASV Study
- Conditions
- Central Sleep Apnea SyndromeIdiopathic Central Sleep Apnea SyndromeObstructive Sleep Apnea Syndrome andComplex Sleep Apnea SyndromeChronic Heart Failure andIdiopathic Induced Periodic Breathing
- Interventions
- Device: Adaptive Servo-Ventilation
- Registration Number
- NCT02429986
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASV Arm Adaptive Servo-Ventilation The measures are performed during the annual consultation required by the French Social Security for the renewal of the reimbursement of the ASV care.
- Primary Outcome Measures
Name Time Method Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings 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. 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
Name Time Method Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency) The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) 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).
Sleep Disorder Breathing involved in the initial prescription of ASV The day of inclusion 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).
Number of hospitalization during the last year and etiology of the hospitalization The day of inclusion 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).
Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported) The day of inclusion 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) The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) 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).
Type of device used nad history of device used (CPAP used before ASV ?) The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) 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)
Used or not of an auto-EPAP The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) 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).
Changes in AHI as compared to baseline The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) 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).
Type of mask used and historical use of mask The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device) 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).
Number of patients not showing up for the annual consultation One year after the start of the study 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).
Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available The day of inclusion 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).
Changes in Asthenia by measuring Pichot scale as compared to baseline if available The day of inclusion 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).
Presence of a cardiomyopathy The day of inclusion 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).
Trial Locations
- Locations (5)
Polyclinic Saint-Privat
🇫🇷Boujan sur Libron, France
CHU Dijon
🇫🇷Dijon, France
Arnaud de Villeneuve University Hospital
🇫🇷Montpellier, France
Hôpital Pitié Salpetrière
🇫🇷Paris, France
Hôpital Nord
🇫🇷Marseille, France