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

NCT05958563 | Recruiting DMC

• 1 other identifier: 49RC21_0377
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 15

Brief Summary

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

Sleep Apnea; COPD Exacerbation; Overlap Syndrome

Keywords

sleep apnea; copd; overlap syndrome

Outcome Measures

Primary Outcomes (1)

• annual rate of COPD exacerbations

  COPD exacerbations will be captured using the EXACT-PRO diary. COPD exacerbations will be defined as a worsening of two or more of dyspnea, sputum purulence or sputum volume for at least two consecutive days and captured using an electronic diary (EXACT-PRO) for mild exacerbation or during clinical visits for moderate and severe exacerbations.

  12 months

Secondary Outcomes (13)

• Annual rate of moderate to severe COPD exacerbations and severe COPD exacerbations

  12 months

• Times to the first COPD exacerbation of any severity

  12 months

• Times to the first COPD exacerbation of the first moderate or severe COPD exacerbation

  12 months

• Times to the first COPD exacerbation of the first severe COPD exacerbation

  12 months

• Annual rate of non-fatal cardiovascular events

  12 months

Study Arms (2)

CPAP group

EXPERIMENTAL

Continuous positive airway pressure (CPAP) for one year

Device: continuous positive airway pressure treatment

Control group

NO INTERVENTION

No CPAP treatment

Interventions

continuous positive airway pressure treatment DEVICE

CPAP treatment for one year

CPAP group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Grade of 2 or higher on the modified Medical Research Council scale (which ranges from 0 to 4, with higher grades indicating more severe dyspnea)
• A post-bronchodilator forced expiratory volume in 1 second (FEV1) of less than 70% of the predicted value, and a postbronchodilator ratio of FEV1 to forced vital capacity (FVC) of less than 0.70.
• Documented history of at least one moderate or severe COPD exacerbation during the previous year
• Clinical suspicion of OSA (based on a STOP-bang questionnaire \>3),
• Have a telephone or a tablet or accept to use one during the study,
• Willing and able to comply with all study procedures,
• Subjects covered by or having the rights to medical care assurance.
• An apnea-hypopnea index \[AHI\], ≥15 per hour based on a full night polysomnography and no significant central apneas (\<5 central apneas per hour of sleep

You may not qualify if:

• Severe daytime sleepiness (Epworth sleepiness Scale \>14/24 and/or frequent sleepiness while driving or patient escaping a sleep-onset accident within the last 12 months),
• Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke),
• Patient on long-term oxygen therapy or non-invasive ventilation
• Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg)
• Previously diagnosed and treated OSA
• Any rehabilitation program or any lung volume reduction procedure planned in the oncoming year
• Pregnancy, breastfeeding
• Bad understanding of the French language,
• Other protected person according to articles L1121.7 and L1121.8 of the French Public Health Act

Sponsors & Collaborators

• University Hospital, Angers: lead
• Ministry of Health, France: collaborator

Study Sites (15)

Angers University Hospital

Angers, France

RECRUITING

Bordeaux University Hospital

Bordeaux, France

RECRUITING

Brest University Hospital

Brest, France

RECRUITING

AP-HP -Henri Mondor Hsopital

Créteil, France

RECRUITING

Dijon University Hospital

Dijon, France

RECRUITING

Grenoble University Hospital

Grenoble, France

RECRUITING

Le Mans Hospital

Le Mans, France

RECRUITING

Nancy University Hospital

Nancy, France

RECRUITING

AP-HP - Pitié Salpetrière Hospital

Paris, France

RECRUITING

Bichat Hospital - AP-HP

Paris, France

RECRUITING

Poitiers University Hospital

Poitiers, France

RECRUITING

Reims University Hospital

Reims, France

RECRUITING

Polyclinique Saint Laurent

Rennes, France

RECRUITING

Strasbourg University Hospital

Strasbourg, France

RECRUITING

Toulouse Universty Hospital

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wojciech Trzepizur, MD PhD

CONTACT

+33680575272; wotrzepizur@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: randomized control study

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 24, 2023
• Study Start: January 9, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

FR (15)