Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea to Detect Early Events of Heart Failure.

March 9, 2021 updated by: Groupe Medical de Pneumologie, Polyclinique Saint-Laurent

Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea for the Early Detection of Significant Cardiac Events.

Obstructive sleep apnea (OSA) syndrome affects 40-60% of patients presenting with cardiovascular diseases. Cheyne-Stokes respiration is a type of central apnea characterised by the presence of at least three consecutive episodes of apnea and/or hypopnea separated by a crescendo-decrescendo variation of the breathing amplitude with a cycle length ≥ 40 seconds and a central apnea/hypopnea index ≥ 5/h, for at least two hours of recording.

The association between heart failure and Cheynes-Stokes respiration is known and a recent study showed that Cheynes-Stokes respiration was associated with more severe heart failure. Moreover, a medical and medical/financial benefit of the early detection of cardiac decompensation has been reported.

The purpose of this feasibility study is to investigate the benefit of Cheyne-Stokes respiration remote monitoring in CPAP-treated patients with OSA for the early detection of significant cardiac events (heart failure, rhythm disorder, diastolic dysfunction).

To achieve this aim, a modified approach of CPAP remote monitoring is proposed based on the performance of the latest generation of positive pressure devices from ResMed, AirSense™ 10 Autoset™, which can detect and record the presence of Cheynes-Stokes respiration. For a period of 12 months, in addition to the usual daily remote monitoring (CPAP adherence, pressure settings, level of air leakages), the healthcare provider will systematically monitor the CSR data whenever the AHI increases significantly. Physicians will be alerted when a CSR occurs and they will see the patients within a short time for pulmology and cardiology consultations in order to screen the onset of significant cardiac event.

After the 12-month period of modified remote monitoring, the telemedicine returns to the usual procedure. Patients who had at least one CSR occurrence during the first 12-month period will be followed up to 24 months to assess their medical condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

555

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35706
        • Polyclinique Saint-Laurent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient with severe OSA treated with CPAP (device AirSense™10 Autoset™ by ResMed).
  • patient followed up by one of the lung specialist of the Polyclinique Saint-Laurent and tele-monitored by the healthcare provider VitalAire.

Exclusion Criteria:

  • enrolled in an interventionnal clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CSR remote monitoring
The remote monitoring of CPAP treatment will be modified in order to detect the presence of CSR as soon as any significant increase of the apnea-hypopnea index occurs.
Other: CSR remote monitoring
The intervention will consist to modify the method used to analyse the data collected by remote monitoring in OSA-patients treated by CPAP (device : AirSense™10 Autoset™, ResMed) in order to alert physicians when Cheynes-Stokes respiration (CSR) occurs during sleep and then to set up emergency pulmonology and cardiology consultations to screen the onset of a significant cardiac event (heart failure, rhythm disorder, diastolic dysfunction).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of significant cardiac events following the detection of Cheyne-Stokes Respiration during sleep
Time Frame: 12 months
To determine the correlation between the occurrence of Cheyne-Stokes Respiration during sleep and the onset of a significant cardiac event during the 12 month period of modified remote monitoring.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterisation of apnea-hypopnea index and CPAP treatment when the Cheyne-Stokes Respiration occurs
Time Frame: throughout the 12 month period
Each time a CSR is detected during sleep, the mean AHI of the last 7 days and the machine settings (the 95th percentile pressure, fixed or autoset mode, level of air leakages, other settings) will be monitored.
throughout the 12 month period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
CPAP treatment adherence
Time Frame: 12 months
The mean number of nights with CPAP use > 4 hours
12 months
Medical condition of patients after CSR occurence
Time Frame: 24 months
To assess the medical condition of patients who had at least one Cheyne-Stokes Respiration during the 12 months modified remote monitoring. The number of pulmonology and cardiology consultations and/or hospitalisations will be monitored up to 24 months.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Medical de Pneumologie, Polyclinique Saint-Laurent

Collaborators

ResMed
Slb Pharma
VitalAire
Regional Health Agency - Brittany

Investigators

  • Principal Investigator: Arnaud Prigent, MD, Groupe Médical Pneumologie - Polyclinique Saint-Laurent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2018

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 20, 2020

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AlertApnée

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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