Clinical trial NCT03592108: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea (OAS)
Cheyne-Stokes respiration (CSR)
Continuous positive airway pressure (CPAP)
Telemedicine
Heart failure
Lead sponsor: Groupe Medical de Pneumologie, Polyclinique Saint-Laurent
Sponsor class: OTHER
Collaborators: name: Slb Pharma
name: VitalAire
name: Regional Health Agency - Brittany
name: ResMed
First posted: 2018-07-19
Enrollment: 555
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: Proportion of significant cardiac events following the detection of Cheyne-Stokes Respiration during sleep
timeFrame: 12 months
Secondary outcomes:
measure: Characterisation of apnea-hypopnea index and CPAP treatment when the Cheyne-Stokes Respiration occurs
timeFrame: throughout the 12 month period
Other outcomes:
measure: CPAP treatment adherence
timeFrame: 12 months
measure: Medical condition of patients after CSR occurence
timeFrame: 24 months
Locations:
city: Rennes
country: France
facility: Polyclinique Saint-Laurent
Study officials:
affiliation: Groupe Médical Pneumologie - Polyclinique Saint-Laurent
name: Arnaud Prigent, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.