Clinical trial NCT02429986: Adaptive Servo-Ventilation in "Real Life" Conditions : the OTRLASV Study
Official title: Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Residual Apnea Hypopnea Index (AHI) evaluated by the ASV device and associated pressure settings
timeFrame: 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 outcomes:
measure: Sleep Disorder Breathing involved in the initial prescription of ASV
timeFrame: The day of inclusion
measure: ASV compliance (number of hour per day, number of day with ≥3 hours in the past 6 months)
timeFrame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
measure: Type of device used nad history of device used (CPAP used before ASV ?)
timeFrame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
measure: Used or not of an auto-EPAP
timeFrame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
measure: Settings of the device (Inspiratory and Expiratory pressures, duration of pressurization, backup frequency)
timeFrame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
measure: Type of mask used and historical use of mask
timeFrame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
measure: Changes in AHI as compared to baseline
timeFrame: The day of inclusion during the consultation or in a maximum delay of 15 days after (if the patient forgot to bring his device)
measure: Changes in Daytime Sleepiness by measuring Epworth scale as compared to baseline if available
timeFrame: The day of inclusion
measure: Changes in Asthenia by measuring Pichot scale as compared to baseline if available
timeFrame: The day of inclusion
measure: Number of hospitalization during the last year and etiology of the hospitalization
timeFrame: The day of inclusion
measure: Presence of a cardiomyopathy
timeFrame: The day of inclusion
measure: Treatment of the cardiomyopathy (medication consumption and use of cardiac implant will be reported)
timeFrame: The day of inclusion
measure: Number of patients not showing up for the annual consultation
timeFrame: One year after the start of the study
Other outcomes:
Locations:
city: Boujan sur Libron
country: France
facility: Polyclinic Saint-Privat
city: Dijon
country: France
facility: CHU Dijon
city: Marseille
country: France
facility: Hôpital Nord
city: Montpellier
country: France
facility: Arnaud de Villeneuve University Hospital
city: Paris
country: France
facility: Hôpital Pitié Salpetrière
Study officials:
affiliation: Polyclinic Saint-Privat
name: Dany JAFFUEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.