NCT02429986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2017

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

April 1, 2015

Last Update Submit

September 24, 2020

Conditions

Chronic Heart Failure andComplex Sleep Apnea SyndromeObstructive Sleep Apnea Syndrome andIdiopathic Central Sleep Apnea SyndromeIdiopathic Induced Periodic BreathingCentral Sleep Apnea Syndrome

Keywords

Adaptive Servo-VentilationChronic Heart FailureCentral Sleep Apnea SyndromeCentral and Obstructive Sleep Apnea SyndromeComplex Sleep Apnea SyndromeHunter-Cheyne-Stokes BreathingPeriodic Breathing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Sleep Disorder Breathing involved in the initial prescription of ASV

    The day of inclusion

  • 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)

  • 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)

  • 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)

  • 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)

  • +8 more secondary outcomes

Study Arms (1)

ASV Arm

OTHER

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

Interventions

Adaptive Servo-VentilationDEVICE

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

ASV Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy, intention of being pregnant, breastfeeding.
  • Inability to understand the nature and aims of the study or to communicate with the investigator
  • No affiliation to the French social security
  • Loss of personal capacity resulting in state protection
  • Deprivation of liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Polyclinic Saint-Privat

Boujan-sur-Libron, 34480, France

Location

CHU Dijon

Dijon, 21079, France

Location

Hôpital Nord

Marseille, 13015, France

Location

Arnaud de Villeneuve University Hospital

Montpellier, 34295, France

Location

Hôpital Pitié Salpetrière

Paris, 75651, France

Location

Related Publications (3)

  • 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.

    PMID: 31665026RESULT

  • 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.

    PMID: 32957983RESULT

  • 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.

    PMID: 27155898RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea, Central

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Dany JAFFUEL, MD, PhD

    Polyclinic Saint-Privat

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 29, 2015

Study Start

March 13, 2015

Primary Completion

January 17, 2017

Study Completion

January 17, 2017

Last Updated

September 25, 2020

Record last verified: 2020-09

Locations

FR(5)