BridgeMD
New treatment option for Sleep Apnea
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)
ClinicalTrials.gov ID: NCT05958563
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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...
- 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),
You likely can't join if
- Severe daytime sleepiness (Epworth sleepiness Scale \>14/24 and/or frequent sleepiness while driving or patient escaping a sleep-onset accident...
- 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
See the full eligibility criteria
- 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,
- people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Bordeaux, France
- Brest, France
- Créteil, France
- Dijon, France
- Grenoble, France
- Le Mans, France
- Nancy, France
- Paris, France
- Poitiers, France
- Reims, France
- Rennes, France
- Strasbourg, France
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Bordeaux, France; Brest, France; Créteil, France; Dijon, France; Grenoble, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.