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

Primary Purpose

Sleep Apnea, COPD Exacerbation, Overlap Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
continuous positive airway pressure treatment
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea focused on measuring sleep apnea, copd, overlap syndrome

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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, 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    CPAP group

    Control group

    Arm Description

    Continuous positive airway pressure (CPAP) for one year

    No CPAP treatment

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Annual rate of moderate to severe COPD exacerbations and severe COPD exacerbations
    The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
    Times to the first COPD exacerbation of any severity
    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.
    Times to the first COPD exacerbation of the first moderate or severe COPD exacerbation
    The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
    Times to the first COPD exacerbation of the first severe COPD exacerbation
    The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
    Annual rate of non-fatal cardiovascular events
    non-fatal myocardial infarction, non-fatal stroke, coronary artery bypass surgery, and percutaneous transluminal coronary angiography
    Mortality rate
    deaths
    Measurement of the quality of life
    Saint George's Respiratory Questionnaire
    Dyspnea
    modified Medical Research Council scale
    Functional respiratory
    forced expiratory volume in one second
    exercise capacity
    6 minutes walking test
    Daytime sleepiness
    Epworth Sleepiness Scale
    Subjective sleep quality
    Pittsburgh sleep quality index
    Arterial blood gases
    Partial pressure of oxygen and carbon dioxide

    Full Information

    First Posted
    July 12, 2023
    Last Updated
    July 20, 2023
    Sponsor
    University Hospital, Angers
    Collaborators
    Ministry of Health, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05958563
    Brief Title
    Impact of Continuous Positive Airway Pressure on the Occurrence of Acute Exacerbations of COPD in Patients With COPD-OSA Overlap Syndrome (CO-OS)
    Acronym
    SLEEPOVEA
    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) SLEEPOVEA
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    January 1, 2028 (Anticipated)
    Study Completion Date
    January 1, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers
    Collaborators
    Ministry of Health, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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".
    Detailed Description
    This study is an open labeled parallel group randomized controlled trial. The patients will be recruited within the pneumology consultations of the participating centers. Patients meeting the pre-inclusion criteria and having no exclusion criteria will be included in the study and will undergo a polysomnographic sleep recording (PSG). Patients with apnea hypopnea index (AHI) <15 / hour and/or significant central apneas (≥5 central apneas per hour of sleep) during PSG will be excluded from the study. Patients with moderate to severe OSA (AHI ≥15 /h) and no significant central apneas will undergo baseline evaluation (ABG, 6 minute walking test, FEV1 and questionnaires) and then will be randomly assigned to receive 1 year of CPAP treatment (CPAP group) or no treatment of OSA (control group) according to a 1:1 allocation using a computer-generated randomization list stratified by site and OSA severity with permuted blocks of random sizes. Visit at 3,6 and 9 months: the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death and questionnaires. Visit at the end of the study (12 months): the following outcomes will be assessed: COPD exacerbations (number, date and severity), cardiovascular events, death, questionnaires, ABG, 6 minute walking test, FEV1. Statistical analysis for primary and secondary outcomes will be performed on an intention to treat basis. A per-protocol analysis will be also performed in patients with an average objective CPAP use of at least 4 hours per day. Pre-specified sensitivity analysis will be conducted according to age, gender, body-mass index, OSA and COPD severity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Apnea, COPD Exacerbation, Overlap Syndrome
    Keywords
    sleep apnea, copd, overlap syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    randomized control study
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CPAP group
    Arm Type
    Experimental
    Arm Description
    Continuous positive airway pressure (CPAP) for one year
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No CPAP treatment
    Intervention Type
    Device
    Intervention Name(s)
    continuous positive airway pressure treatment
    Intervention Description
    CPAP treatment for one year
    Primary Outcome Measure Information:
    Title
    annual rate of COPD exacerbations
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Annual rate of moderate to severe COPD exacerbations and severe COPD exacerbations
    Description
    The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
    Time Frame
    12 months
    Title
    Times to the first COPD exacerbation of any severity
    Description
    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.
    Time Frame
    12 months
    Title
    Times to the first COPD exacerbation of the first moderate or severe COPD exacerbation
    Description
    The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
    Time Frame
    12 months
    Title
    Times to the first COPD exacerbation of the first severe COPD exacerbation
    Description
    The type of treatment provided for a COPD exacerbation will determine the severity of the exacerbation. It will be categorized as mild (involving worsening of symptoms for >2 consecutive days), moderate (leading to treatment with glucocorticoids, antibiotics, or both), or severe (leading to hospital admission)
    Time Frame
    12 months
    Title
    Annual rate of non-fatal cardiovascular events
    Description
    non-fatal myocardial infarction, non-fatal stroke, coronary artery bypass surgery, and percutaneous transluminal coronary angiography
    Time Frame
    12 months
    Title
    Mortality rate
    Description
    deaths
    Time Frame
    12 months
    Title
    Measurement of the quality of life
    Description
    Saint George's Respiratory Questionnaire
    Time Frame
    12 months
    Title
    Dyspnea
    Description
    modified Medical Research Council scale
    Time Frame
    12 months
    Title
    Functional respiratory
    Description
    forced expiratory volume in one second
    Time Frame
    12 months
    Title
    exercise capacity
    Description
    6 minutes walking test
    Time Frame
    12 months
    Title
    Daytime sleepiness
    Description
    Epworth Sleepiness Scale
    Time Frame
    12 months
    Title
    Subjective sleep quality
    Description
    Pittsburgh sleep quality index
    Time Frame
    12 months
    Title
    Arterial blood gases
    Description
    Partial pressure of oxygen and carbon dioxide
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion 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, 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wojciech Trzepizur, MD PhD
    Phone
    +33680575272
    Email
    wotrzepizur@chu-angers.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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