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NOT YET RECRUITING
NCT07047092
PHASE3

Non-invasive Ventilation or CPAP in OSA-COPD Following Admission for an Acute Hypercapnic Respiratory Failure

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

386

Start Date

2025-09

Completion Date

2030-10

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DEVICE

Non-invasive Ventilation (NIV)

Patients 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.

DEVICE

Continous Positive Airway Pressure (CPAP)

Patients 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.

Locations (1)

Hospital Pitié-Salpêtrière - Sleep unit, R3S Departement

Paris, France