Actively Recruiting
The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
Led by University of California, San Diego · Updated on 2026-06-03
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the cardiovascular effects in people who have both obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD), a condition known as overlap syndrome (OVS). This study aims to understand how OVS affects heart and blood vessel health compared to having OSA or COPD alone. It also seeks to explore potential treatments to improve cardiovascular outcomes in these patients, addressing gaps in knowledge about how these conditions together contribute to heart problems. The study has two main parts. The first part compares blood vessel health markers among people with OVS, OSA alone, and COPD alone. The second part is a randomized clinical trial where participants with OVS will receive either bi-level positive airway pressure (PAP) therapy or nocturnal oxygen therapy for six months. Bi-level PAP uses a device that delivers varying air pressures to support breathing at night, while oxygen therapy provides a steady flow of oxygen. Participants will be trained to use their assigned therapy and monitored regularly for adherence. Participants will first complete screening and eligibility assessments including medical history, lung function tests, questionnaires, and overnight sleep studies. Those eligible will visit the research lab for detailed evaluations such as physical exams, blood tests, heart imaging (cardiac MRI), and cognitive tests. After six months of treatment, OVS participants will return for repeat assessments to measure changes in heart health, biomarkers, and cognitive function. The study will monitor outcomes like right ventricular heart muscle mass and vascular health markers to evaluate the effects of the therapies over this period.
CONDITIONS
Brief Title
The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form.
- Willingness to comply with all study procedures and available for the study duration.
- Age between 40 and 79 years.
- Postmenopausal women only.
- Diagnosed with untreated moderate to severe obstructive sleep apnea (AHI ≥15 and ≤80 events/hour) and/or diagnosed with COPD with FEV1/FVC ratio <0.7 and on stable medications as assessed by a pulmonologist.
You will not qualify if you...
- Premenopausal women (pregnant or may become pregnant) or breastfeeding.
- Presence of implanted devices such as pacemakers, defibrillators, neurostimulation systems, cochlear implants, drug infusion pumps, metallic fragments, aneurysm clips, magnetic dental implants, or artificial limbs.
- Known allergies to study intervention components.
- Severe concurrent sleep disorders (e.g., narcolepsy, restless legs syndrome).
- Cheyne-Stokes respiration or central sleep apnea (>25% central events).
- Use of medications or hormones affecting breathing.
- Medically unstable with active neurological, cardiac, liver, endocrine, or infectious diseases.
- Pulmonary diseases other than COPD.
- Active cancer treatment.
- Azotemia with estimated glomerular filtration rate <30 ml/min.
- Exposure to significant second-hand smoke, e-cigarettes, THC, major drug or alcohol use (>3 oz/day), or environmental pollution.
- Current use of continuous oxygen or positive airway pressure therapy.
- Sustained daytime oxygen desaturation below 89%.
- Severe sleepiness or high-risk behavior related to OSA.
- COPD with arterial PCO2 over 52 mmHg.
- Current incarceration.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Initial eligibility screening online or by phone (~10 minutes) and in-person eligibility assessment (~1.5 hours) including history, exam, questionnaires, spirometry, and an overnight home sleep test.
Duration - 1 day
Participants who are eligible will have an overnight visit at the research lab including exams, questionnaires, blood tests, cardiovascular health measures, neurocognitive function tests, pulmonary function test, and an overnight sleep study to assess sleep apnea severity.
1 overnight visit (~12 hours) and 1 daytime visit for cardiac MRI
Duration - 6 months
Participants with overlap syndrome (OVS) who tolerate mask adaptation will be randomized to receive either bi-level positive pressure ventilation or nocturnal oxygen therapy for 6 months, with adherence monitored by weekly calls from the research team.
Mask adaptation day visit followed by weekly adherence calls during treatment
Duration - 2 days
After 6 months of treatment, participants with OVS will return for an overnight visit including exams, questionnaires, blood tests, cardiovascular health measures, neurocognitive tests, and an overnight sleep study, as well as a daytime cardiac MRI visit to assess treatment effects.
1 overnight visit and 1 daytime visit for cardiac MRI
Trial Site Locations
Total: 1 location
1
UCSD Sleep Research
La Jolla, California, United States, 92037
Actively Recruiting
Research Team
P
Pamela DeYoung, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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