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

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ClinicalTrials.gov Identifier: NCT02429986
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Device: Adaptive Servo-Ventilation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observational and Transversal Study of Patients Treated in "Real Life"Conditions With Adaptive Servo-Ventilation
Actual Study Start Date : March 13, 2015
Actual Primary Completion Date : January 17, 2017
Actual Study Completion Date : January 17, 2017

Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429986


Locations
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France
Polyclinic Saint-Privat
Boujan sur Libron, France, 34480
CHU Dijon
Dijon, France, 21079
Hôpital Nord
Marseille, France, 13015
Arnaud de Villeneuve University Hospital
Montpellier, France, 34295
Hôpital Pitié Salpetrière
Paris, France, 75651
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Dany JAFFUEL, MD, PhD Polyclinic Saint-Privat
Publications of Results:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02429986    
Other Study ID Numbers: 9498
2014-A01565-42 ( Other Identifier: RCB number )
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: March 2017
Keywords provided by University Hospital, Montpellier:
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
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Aspiration
Sleep Apnea, Central
Heart Failure
Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases