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

NCT03592108 | Completed

• 1 other identifier: AlertApnée
• Study Type: interventional
• Target: 555
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea (OAS); Cheyne-Stokes respiration (CSR); Continuous positive airway pressure (CPAP); Telemedicine; Heart failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Characterisation of apnea-hypopnea index and CPAP treatment when the Cheyne-Stokes Respiration occurs

  throughout the 12 month period

Other Outcomes (2)

• CPAP treatment adherence

  12 months

• Medical condition of patients after CSR occurence

  24 months

Study Arms (1)

CSR remote monitoring

EXPERIMENTAL

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

Interventions

CSR remote monitoring 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).

CSR remote monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• enrolled in an interventionnal clinical trial.

Sponsors & Collaborators

• Groupe Medical de Pneumologie, Polyclinique Saint-Laurent: lead
• Slb Pharma: collaborator
• VitalAire: collaborator
• Regional Health Agency - Brittany: collaborator
• ResMed: collaborator

Study Sites (1)

Polyclinique Saint-Laurent

Rennes, 35706, France

Location

Related Publications (1)

• 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.

  PMID: 34873795 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Cheyne-Stokes Respiration; Heart Failure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Arnaud Prigent, MD

  Groupe Médical Pneumologie - Polyclinique Saint-Laurent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: July 30, 2018
• Primary Completion: October 1, 2019
• Study Completion: October 20, 2020
• Last Updated: March 10, 2021

Record last verified: 2020-03

Locations

FR (1)