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NCT Number: NCT02429986

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

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.

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Key information

Conditions

Chronic Heart Failure and Apnea Central Sleep Apnea Syndrome Complex Sleep Apnea Syndrome Dyssomnias Idiopathic Central Sleep Apnea Syndrome Idiopathic Induced Periodic Breathing Nervous System Diseases Obstructive Sleep Apnea Syndrome and Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Central Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinic Saint-Privat, Boujan-sur-Libron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adaptive Servo-Ventilation

Device

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

Primary outcomes

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

    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.

    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 outcomes

  1. Sleep Disorder Breathing involved in the initial prescription of ASV

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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)

  4. Used or not of an auto-EPAP

    Time frame: 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).

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

    Time frame: 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).

  6. Type of mask used and historical use of mask

    Time frame: 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).

  7. Changes in AHI as compared to baseline

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

  11. Presence of a cardiomyopathy

    Time frame: 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).

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

    Time frame: 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).

  13. Number of patients not showing up for the annual consultation

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: OTRLASV

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2015
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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