Prevalence of OSA in COPD and the Clinical Impact of OSA Diagnosis and Treatment (NCT05042154) | Clinical Trial Compass
UnknownNot Applicable
Prevalence of OSA in COPD and the Clinical Impact of OSA Diagnosis and Treatment
300 participantsStarted 2021-10-31
Plain-language summary
COPD is a major cause of morbidity and mortality and is characterized by breathing impairment and related symptoms. Obstructive sleep apnea (OSA) is a highly prevalent condition that adversely affects breathing during sleep. The co-occurrence of OSA and COPD in an individual has been referred to as the overlap syndrome (OVS). Regardless of whether OVS represents a single unique entity or two separate conditions in the same patient, the combined respiratory derangements of OSA and COPD are felt to be synergistic. Patients with COPD and OSA may have more frequent and severe nocturnal arterial hypoxemia and hypercapnia than in patients with OSA alone, as well as increased pulmonary hypertension and dysrhythmias. The reported prevalence of OSA in COPD varies widely depending on patient setting, COPD severity, diagnostic methodology, etc., ranging from 10 to 75%. The presence of OSA in patients with COPD has also been implicated as a risk factor for COPD exacerbations and associated hospitalizations.
The coexistence of OSA and COPD is associated with increased risk of COPD exacerbation and shorter time to first exacerbation following diagnosis. 20% of patients discharged following an exacerbation of COPD are readmitted within 30 days, usually for respiratory-related problems.
A randomized controlled trial on Gagnon 3 at Morristown Medical Center will be conducted to diagnose OSA in patients admitted with AECOPD. The WatchPAT One device will be used and can detect the presence of OSA. If OSA is diagnosed, the patient will then be offered and prescribed a home CPAP for use after hospital discharge. We will investigate 30-day of AECOPD readmission rates.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: Inclusion criteria include GOLD stage 3 or 4 for outpatients and for in-patients, criteria will include an admission diagnosis of AECOPD, age greater than 18 years, ability to participate in a supine sleep study, known COPD diagnosed by a pulmonologist (GOLD stage 3 or 4). Informed consent will be obtained from each patient. The study population will be composed of patients admitted to Gagnon 3 from the emergency department (ED) and to 10 CD from the ED. All new admissions to Gagnon 3 at MMC and 10 CD at OMC will be screened daily by study personnel for enrollment using the author's inclusion and exclusions criteria. Permission to approach patients and families will be requested from the attending pulmonologist.
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Exclusion Criteria: a. List exclusion criteria:
We excluded patients unable or unwilling to participate in the home sleep study, medical problems or medications affecting the diagnostic accuracy/application of WatchPAT One (peripheral vascular disease, peripheral neuropathy, alpha blockade), admission to the ICU, finger deformity which prevented adequate sensor application.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.