Chronic obstructive pulmonary disease (COPD) is a major public health problem with 212.3 million prevalent cases of COPD worldwide and 3.3 million deaths related to COPD in 2019. Obstructive sleep apnoea (OSA) is the most common sleep disordered breathing. It is estimated that almost 1 billion adults have OSA worldwide.
Given the increasing prevalence of obesity, co-morbid OSA is frequently seen in patients with COPD. Co-morbid OSA has been shown to increase mortality, to reduce quality of life and to favour acute exacerbation of COPD. For those admitted for a life-threatening exacerbation of COPD requiring an intensive care admission for acute hypercapnic failure, they are more likely to get readmitted. For those admitted for an acute exacerbation in any ward, they are more likely to be re-admitted for another exacerbation within 180-days if their OSA is not treated.
Unfortunately, data regarding the best management of OSA in patients with co-morbid COPD are lacking as they were often excluded from clinical trials involving patients with COPD. Therefore, CPAP or NIV are administered without scientific evidence establishing which treatment is the most appropriate.
Age ≥ 18 and < 85 years
Patient with a diagnosis of COPD according to GOLD guidelines
Patient admitted for an acute exacerbation of COPD requiring acute NIV or invasive ventilation or high-flow therapy (pH <7.35 with PaCO2 >45mmHg/6kPa)
Patient that has been weaned from acute NIV or invasive ventilation or high flow therapy
Patient with NIV treatment
Patients who decline any use of NIV or CPAP in the home setting
Significant psychiatric disorder or dementia that would prevent adherence to study protocol
Tobacco use <10 pack-year
Parallel
Non-invasive Ventilation (NIV)
DevicePatients will receive a dedicated training for the use of their NIV in the home setting. The training is the same provided in the usual care of patients established on NIV. They will choose a home care provider for the delivery of NIV as per standard care in France. A telemonitoring of adherence to NIV will be performed.
Continous Positive Airway Pressure (CPAP)
DevicePatients will receive a dedicated training the use of their CPAP in the home setting. The training is the same provided in the usual care of patients established on CPAP. They will choose a home care provider for the delivery of CPAP as per standard care in France. Follow-up of CPAP will be performed according to standard care in France and will therefore include a telemonitoring of adherence to CPAP.
Demonstrate the superiority of home NIV versus home CPAP for the reduction of severe exacerbation of COPD or death.
Reduction of severe exacerbation of COPD or death, defined by the time to occurrence of (i) death from any cause or (ii) hospitalization in relation to severe exacerbation of COPD during a follow up of 12 months after randomization.
Evaluate the benefit of NIV over CPAP regarding control of sleep disordered breathing
Control of sleep disordered breathing, defined as evolution between baseline and 1 year follow-up of the following combined criteria : * Apnea-hypopnea index (whilst unsupported breathing at baseline and when using the treatment overnight) * 3% Oxygen desaturation index (whilst unsupported breathing at baseline and when using the treatment overnight) * Proportion of time spent with SpO2 \<90% (whilst unsupported breathing at baseline and when using the treatment overnight) * Change in 3% Oxygen desaturation index between baseline at 3- and 6-months follow-up when using the treatment overnight * Proportion of time spent with SpO2 \<90% at 3 months and 6 months when using the treatment overnight.
Quality of life of NIV over CPAP
HRQOL compared at 3 months follow-up using HRQOL questionnaires.
Quality of life of NIV over CPAP
HRQOL compared at 12 months follow-up using HRQOL questionnaires.
Quality of sleep of NIV over CPAP (Pittsburgh Sleep Quality Index).
Change in quality of sleep will be assessed using quality of sleep evaluation scales (Pittsburgh Sleep Quality Index).
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