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NCT05958563Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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".

Status (registry)
Recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
12 Jul 2023
Start date
9 Jan 2024
Primary completion date
1 Jan 2028
Lead sponsor
University Hospital, Angers
Diseases
COPD
NCT number
NCT05958563

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 9 Jan 2024 to the primary completion date, 1 Jan 2028
  • 15 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient on long-term oxygen therapy or non-invasive ventilation
  • Previously documented severe hypercapnia (PaCO2 ≥ 50mm Hg)
  • Previously diagnosed and treated OSA

Other illness

  • Severe unstable cardiovascular disease (heart failure with FEVG≤45%, recurrent cardiac arrhythmia, instable coronary heart disease or stroke),

Other

  • 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),
  • 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

Who the study is looking for

  • 40 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

Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (15)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Angers University Hospital
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AngersFranceRecruiting
Bordeaux University Hospital
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BordeauxFranceRecruiting
Brest University Hospital
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BrestFranceRecruiting
AP-HP -Henri Mondor Hsopital
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CréteilFranceRecruiting
Dijon University Hospital
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DijonFranceRecruiting
Grenoble University Hospital
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GrenobleFranceRecruiting
Le Mans Hospital
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Le MansFranceRecruiting
Nancy University Hospital
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NancyFranceRecruiting
AP-HP - Pitié-Salpêtrière Hospital
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ParisFranceRecruiting
Bichat Hospital - AP-HP
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ParisFranceRecruiting
Poitiers University Hospital
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PoitiersFranceRecruiting
Reims University Hospital
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ReimsFranceRecruiting
Polyclinique Saint Laurent
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RennesFranceRecruiting
Strasbourg University Hospital
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StrasbourgFranceRecruiting
Toulouse Universty Hospital
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ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.