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

Obstructive Sleep Apnea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592108
• Other study ID #: AlertApnée
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: October 20, 2020

Study information

• Verified date: March 2020
• Source: Groupe Medical de Pneumologie, Polyclinique Saint-Laurent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 555
• Est. completion date: October 20, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Cheyne-Stokes Respiration
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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).

Locations

Country	Name	City	State
France	Polyclinique Saint-Laurent	Rennes

Sponsors (5)

Lead Sponsor	Collaborator
Groupe Medical de Pneumologie, Polyclinique Saint-Laurent	Regional Health Agency - Brittany, ResMed, Slb Pharma, Vitalaire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	CPAP treatment adherence	The mean number of nights with CPAP use > 4 hours	12 months
Other	Medical condition of patients after CSR occurence	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
Primary	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.	12 months
Secondary	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.	throughout the 12 month period