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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Angers University Hospital
RECRUITING
Angers
Bordeaux University Hospital
RECRUITING
Bordeaux
Brest University Hospital
RECRUITING
Brest
AP-HP -Henri Mondor Hsopital
RECRUITING
Créteil
Dijon University Hospital
RECRUITING
Dijon
Grenoble University Hospital
RECRUITING
Grenoble
Le Mans Hospital
RECRUITING
Le Mans
Nancy University Hospital
RECRUITING
Nancy
AP-HP - Pitié Salpetrière Hospital
RECRUITING
Paris
Bichat Hospital - AP-HP
RECRUITING
Paris
Poitiers University Hospital
RECRUITING
Poitiers
Reims University Hospital
RECRUITING
Reims
Polyclinique Saint Laurent
RECRUITING
Rennes
Strasbourg University Hospital
RECRUITING
Strasbourg
Toulouse Universty Hospital
RECRUITING
Toulouse
Contact Information
Primary
Wojciech Trzepizur, MD PhD
wotrzepizur@chu-angers.fr
+33680575272
Time Frame
Start Date: 2024-01-09
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 500
Treatments
Experimental: CPAP group
Continuous positive airway pressure (CPAP) for one year
No_intervention: Control group
No CPAP treatment
Sponsors
Leads: University Hospital, Angers
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov