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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-30

Study Completion Date

2020-10-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CSR remote monitoring

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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.