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Completed

NCT Number: NCT03592108

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 (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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Key information

Conditions

Obstructive Sleep Apnea Apnea Cardiovascular Diseases Cheyne-Stokes Respiration Dyssomnias Heart Diseases Heart Failure Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polyclinique Saint-Laurent

Rennes, 35706, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. Proportion of significant cardiac events following the detection of Cheyne-Stokes Respiration during sleep

    Time frame: 12 months

    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 outcomes

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

    Time frame: throughout the 12 month period

    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.

Other outcomes

  1. CPAP treatment adherence

    Time frame: 12 months

    The mean number of nights with CPAP use > 4 hours

  2. Medical condition of patients after CSR occurence

    Time frame: 24 months

    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.

Sponsors and collaborators

Lead sponsor

Groupe Medical de Pneumologie, Polyclinique Saint-Laurent

Other

Collaborators

  • Regional Health Agency - Brittany
  • ResMed
  • Slb Pharma
  • VitalAire

Registry information

Official study title

Benefit of Cheyne-Stokes Respiration Remote Monitoring in CPAP-treated Patients With Obstructive Sleep Apnea for the Early Detection of Significant Cardiac Events.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jul 19, 2018
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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