Effects of Sleep Apnea and COPD on Heart Health

At a Glance

Age: 40 – 79
Sex: Any
Trial phase: Phase 2
Study type: Interventional
Purpose: Treatment
Participants needed: 240 (estimated)
Sponsor: University of California, San Diego · Other

Who this trial is looking for

This trial is looking for people aged 40 to 79 with untreated moderate to severe sleep apnea or chronic obstructive pulmonary disease (COPD). Participants will help researchers understand the effects of these conditions on heart health.

Are You a Good Fit for This Trial?

You may be able to join if

I am aged 40 to 79.
I have signed the consent form.
I have untreated moderate to severe obstructive sleep apnea.
I have been diagnosed with COPD.
I am willing to follow all study procedures.
I will be on stable medications as checked by a specialist.
I am a postmenopausal woman.

You may not be able to join if

I am a premenopausal woman.
I have certain implanted devices like a pacemaker.
I have known allergies to MRI contrast.
I have severe sleep disorders like narcolepsy.
I have unstable medical issues such as active infections.
I have pulmonary diseases other than COPD.
I am currently using continuous oxygen for COPD.
I have been deemed medically unstable.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

About This Trial

Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocogn…

Major progress has been made in the area of cardiovascular disease, but we believe that further progress will involve mechanistically addressing underlying respiratory causes including chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). The most common cause of death in COPD is cardiovascular, although mechanisms are unknown. OSA has been associated with major neurocognitive and cardiovascular sequelae, the latter likely a function of autonomic nervous system abnormalities, oxidative stress, inflammation, and other pathways. Recent data suggest that individuals with OVS die preferentially of cardiovascular disease compared to OSA or COPD alone, although mechanisms are again unclear. The combination of OSA and COPD may lead to profound hypoxemia. Individuals with COPD can develop pulmonary hypertension via disturbances in gas exchange and parenchymal injury leading to loss of pulmonary vasculature. OSA has been associated with mild to moderate pulmonary hypertension, but the situation may be worse if combined with parenchymal lung disease. The biological response to sustained hypoxemia has been carefully studied as has the topic of intermittent hypoxemia; however, to our knowledge, very little research has occurred regarding the combination of sustained plus intermittent hypoxia as seen in OVS. For example, we do not really know whether individuals with OVS develop coronary disease, right or left heart failure, dysrhythmias or some combination of abnormalities predisposing them to cardiovascular death. Thus, design of interventional studies is challenging as causal pathways are poorly understood despite our considerable preliminary data addressing these issues. The purpose of this study is to examine vascular mechanisms in individuals with COPD/OSA overlap syndrome (OVS) compared with matched individuals with obstructive sleep apnea (OSA) alone or chronic obstructive pulmonary disease (COPD) alone and to perform a phase II pilot mechanistic clinical trial in OVS to examine the effect size of nocturnal bi-level positive airway pressure (PAP) vs. nocturnal oxygen therapy in cardiovascular outcomes.

Trial Locations

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Eligibility Criteria

Inclusion Criteria: * 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 se…

Inclusion Criteria: * 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 Criteria: * 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.

Contacts

Pamela DeYoung, BA

8582462183

pdeyoung@health.ucsd.edu

CONTACT

Effects of Sleep Apnea and COPD on Heart Health

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