Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT05958563

Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)

Led by University Hospital, Angers · Updated on 2025-04-13

500

Participants Needed

15

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Angers

Lead Sponsor

M

Ministry of Health, France

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA) are both frequent respiratory diseases with estimated prevalences between 8 and 15% of the adult population. Because of those high prevalences those two entities are often associated in same patients (1 to 4% of the general population). This association is then referred to as Overlap Syndrome (CO-OS). Data from observational studies suggest that this association may have an additive or even synergistic negative impact on patient's prognosis. Indeed, in a cohort of patients diagnosed as having a CO-OS, patients who did not receive specific treatment for OSA had a 76% increased risk of death compared to patients treated with continuous positive airway pressure (CPAP) and a 2-fold increased risk of acute COPD exacerbation. In another cohort of patients with both OSA and severe oxygen treated COPD, untreated patients for OSA had a 5-fold increased risk of death compared to patients treated with CPAP. There are strong signals from observational studies in support of a beneficial impact of CPAP therapy on respiratory outcomes in patients with CO-OS. However, those findings are not supported by any controlled study. It is difficult to directly transpose the observational data to current clinical practice in the context of the recent studies on the impact of CPAP on OSA prognosis. Indeed, data from similar observational OSA cohorts have reported a major impact of CPAP on the overall survival and cardiovascular outcomes in patients with OSA. Ten years later, this impact has not been confirmed by several randomized studies. To date, there is no consensus on a systematic screening and, if present, management of OSA in patients with COPD. The need for specific research on that field was emphasized in 2018 in an official American Thoracic Society Research Statement which recommends "randomized trials that compare clinical outcomes among patients with Overlap Syndrome whose OSA is treated to clinical outcomes among patients with Overlap Syndrome whose OSA is untreated".

CONDITIONS

Official Title

Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 40 years of age or older
  • Grade of 2 or higher on the modified Medical Research Council scale
  • Post-bronchodilator FEV1 less than 70% predicted and FEV1/FVC ratio less than 0.70
  • History of at least one moderate or severe COPD exacerbation in the previous year
  • Clinical suspicion of OSA based on a STOP-bang questionnaire score greater than 3
  • Have or willing to use a telephone or tablet during the study
  • Willing and able to comply with all study procedures
  • Covered by or have rights to medical care assurance
  • Apnea-hypopnea index of 15 or more per hour with less than 5 central apneas per hour on polysomnography
Not Eligible

You will not qualify if you...

  • Severe daytime sleepiness (Epworth sleepiness scale >14/24 or frequent sleepiness while driving or history of sleep-onset accident in last 12 months)
  • Severe unstable cardiovascular disease (heart failure with left ventricular ejection fraction ≤45%, recurrent arrhythmia, unstable coronary heart disease or stroke)
  • On long-term oxygen therapy or non-invasive ventilation
  • Previously documented severe hypercapnia (PaCO2 ≥50 mm Hg)
  • Previously diagnosed and treated obstructive sleep apnea
  • Planned rehabilitation program or lung volume reduction procedure within the next year
  • Pregnancy or breastfeeding
  • Poor understanding of French language
  • Protected person according to articles L1121.7 and L1121.8 of the French Public Health Act

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 15 locations

1

Angers University Hospital

Angers, France

Actively Recruiting

2

Bordeaux University Hospital

Bordeaux, France

Actively Recruiting

3

Brest University Hospital

Brest, France

Actively Recruiting

4

AP-HP -Henri Mondor Hsopital

Créteil, France

Actively Recruiting

5

Dijon University Hospital

Dijon, France

Actively Recruiting

6

Grenoble University Hospital

Grenoble, France

Actively Recruiting

7

Le Mans Hospital

Le Mans, France

Actively Recruiting

8

Nancy University Hospital

Nancy, France

Actively Recruiting

9

AP-HP - Pitié Salpetrière Hospital

Paris, France

Actively Recruiting

10

Bichat Hospital - AP-HP

Paris, France

Actively Recruiting

11

Poitiers University Hospital

Poitiers, France

Actively Recruiting

12

Reims University Hospital

Reims, France

Actively Recruiting

13

Polyclinique Saint Laurent

Rennes, France

Actively Recruiting

14

Strasbourg University Hospital

Strasbourg, France

Actively Recruiting

15

Toulouse Universty Hospital

Toulouse, France

Actively Recruiting

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Research Team

W

Wojciech Trzepizur, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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