Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea to Detect Early Events of Heart Failure.
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CSR remote monitoring
Sponsored by
About this trial
This is an interventional screening trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea (OAS), Cheyne-Stokes respiration (CSR), Continuous positive airway pressure (CPAP), Telemedicine, Heart failure
Eligibility Criteria
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.
Sites / Locations
- Polyclinique Saint-Laurent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CSR remote monitoring
Arm Description
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.
Outcomes
Primary Outcome Measures
Proportion of significant cardiac events following the detection of Cheyne-Stokes Respiration during sleep
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.
Secondary Outcome Measures
Characterisation of apnea-hypopnea index and CPAP treatment when the Cheyne-Stokes Respiration occurs
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.
Full Information
NCT ID
NCT03592108
First Posted
July 9, 2018
Last Updated
March 9, 2021
Sponsor
Groupe Medical de Pneumologie, Polyclinique Saint-Laurent
Collaborators
Slb Pharma, VitalAire, Regional Health Agency - Brittany, ResMed
1. Study Identification
Unique Protocol Identification Number
NCT03592108
Brief Title
Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea to Detect Early Events of Heart Failure.
Official Title
Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea for the Early Detection of Significant Cardiac Events.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 30, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Medical de Pneumologie, Polyclinique Saint-Laurent
Collaborators
Slb Pharma, VitalAire, Regional Health Agency - Brittany, ResMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive sleep apnea (OAS), Cheyne-Stokes respiration (CSR), Continuous positive airway pressure (CPAP), Telemedicine, Heart failure
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
555 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CSR remote monitoring
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CSR remote monitoring
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of significant cardiac events following the detection of Cheyne-Stokes Respiration during sleep
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Characterisation of apnea-hypopnea index and CPAP treatment when the Cheyne-Stokes Respiration occurs
Description
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.
Time Frame
throughout the 12 month period
Other Pre-specified Outcome Measures:
Title
CPAP treatment adherence
Description
The mean number of nights with CPAP use > 4 hours
Time Frame
12 months
Title
Medical condition of patients after CSR occurence
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Prigent, MD
Organizational Affiliation
Groupe Médical Pneumologie - Polyclinique Saint-Laurent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Polyclinique Saint-Laurent
City
Rennes
ZIP/Postal Code
35706
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
34873795
Citation
Prigent A, Pellen C, Texereau J, Bailly S, Coquerel N, Gervais R, Liegaux JM, Luraine R, Renaud JC, Serandour AL, Pepin JL. CPAP telemonitoring can track Cheyne-Stokes respiration and detect serious cardiac events: The AlertApnee Study. Respirology. 2022 Feb;27(2):161-169. doi: 10.1111/resp.14192. Epub 2021 Dec 6.
Results Reference
derived
Learn more about this trial
Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea to Detect Early Events of Heart Failure.
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