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NCT05237505

The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)

Recruiting
PHASE2Ages 40–79InterventionalTreatment
University of California, San Diego
~240 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:bi-level positive pressure non invasive ventilationOxygen gas

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Right ventricular mass
Measured over 6 Months
+3 more outcomes measured

Conditions

Obstructive Sleep Apnea
Chronic Obstructive Pulmonary Disease
Overlap Syndrome

Explore related trials

Chronic Obstructive Pulmonary DiseaseObstructive Sleep ApneaOverlap Syndrome

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Atul Malhotra, MD · PRINCIPAL_INVESTIGATOR · UCSD

Who to contact

Pamela DeYoung, BA
[email protected]
8582462183
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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Persons aged 40-79.
For women, only postmenopausal women will be included
Diagnosed with untreated moderate to severe obstructive sleep apnea (apnea-hypopnea index ≥15 events/hr and ≤80 events/hr) and/or diagnosed with COPD with FEV1/FVC ratio \<0.7 and will be on stable medications as assessed by a board-certified pulmonologist.

Exclusion

Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation
Presence of specific devices: cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices, metallic foreign bodies, implantable neurostimulation systems, cochlear implants/ear implant, drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps), metallic fragments such as bullets, shotgun pellets, and metal shrapnel , cerebral artery aneurysm clips, magnetic dental implants, and artificial limb.
Known allergic reactions to components of the study intervention: (if getting contrast, MRI contrast (gadolinium)).
Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).
Exhibit Cheyne-Stokes respiration or central sleep apnea (\> 25 % of events central)
Take potentially confounding medications or hormones that affect breathing.
Subjects will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.
We will also exclude participants with pulmonary disease apart from COPD.
We will exclude participants with active cancer treatment.
We will exclude azotemia (estimated glomerular fraction rate \< 30ml/min) as there is some concern about giving gadolinium to these patients (if getting contrast MRI).
people with exposures deemed to be problematic for the research e.g. any smoking in bedroom by participant or household member, major second-hand smoke, e-cigarettes, tetrahydrocannabinol, major drug or alcohol consumption (\>3 oz/day) and other environmental pollution effects (indoor and outdoor).
Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.
Patients with sustained desaturations below 89% during wake time will be excluded for ethical reasons since withholding oxygen in hypoxemic patients would be at odds with standard of care.
Individuals with OSA (AHI range 15-80/hr) will be screened for pathological sleepiness and will be excluded if ESS \>18/24, history of motor vehicle accident or near miss accident, or high-risk occupation.
COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.
Individuals who are currently incarcerated.

What this trial measures

  • Right ventricular mass6 Months

    Cardiac magnet resonance imaging (CMRI): All subjects will undergo cardiac MRI measurements the same day they undergo the evaluation of vascular reactivity measurements. Supine cardiac MRI imaging will be performed using a 3T MR scanner (GE 750, GE Healthcare) with a 16-element cardiac coil for radiofrequency signal reception. Non-invasive blood pressure will be monitored during cardiac MRI scanning (Dinemap). Standard and novel MRI sequences will be used for myocardial tissue characterization, assessment of ventricular function, pulmonary hemodynamics, and aortic compliance

  • Reactive Hyperemia Index6 months

    Based on a device called EndoPAT, which measures non-invasively bloodflow before, during, and after 5-minutes of occlusion to one arm.

  • 5th generation troponin6 months

    Troponin will be measured from participant serum samples. Troponin is a marker of myocardial injury.

  • MiR-2106 months

    MicroRNA-210 will be measured from participant serum samples. miR210 may predict risk of atherosclerosis and changes in levels may give insight into mechanisms of our interventions