RightFit
RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 79 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Additionally, they will have a day time visit for the Cardiac MRI."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at heart and blood vessel problems in people with sleep apnea, COPD, or both. Sleep apnea causes breathing pauses during sleep, and COPD is a long-term lung disease that makes breathing hard. In people with both conditions, the study also compares nighttime air pressure treatment through a mask with nighttime oxygen treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40–79 years old.
  • Sign and date a form agreeing to join the study.
  • Be willing to follow all study steps and be available for the whole study.
  • For women, have gone through menopause.
  • Have untreated moderate to severe sleep apnea, COPD, or both. Sleep apnea must cause 15–80 breathing pauses or slowdowns per hour. COPD must meet a breathing test cutoff called FEV1/FVC below 0.7, with medicines kept stable as checked by a lung doctor.

Who can't join

  • Have not gone through menopause, are pregnant or could become pregnant, or are breastfeeding.
  • Have certain implants, devices, or metal in the body, such as a pacemaker, heart shock device, nerve stimulator, ear implant, medicine pump, brain artery clip, magnetic dental implant, metal fragments, or an artificial limb.
  • Have an allergy to the MRI dye gadolinium or very poor kidney function (eGFR below 30), if getting an MRI with this dye.
  • Have another severe sleep disorder; a repeated pattern of deep, shallow, and paused breathing; or sleep apnea where over 25% of pauses come from missing brain signals. People with sleep apnea are also excluded for a sleepiness score above 18 out of 24, a past vehicle crash or near miss, or a high-risk job.
  • Take medicines or hormones that affect breathing, have an unstable brain, nerve, heart, liver, or hormone disease or infection, have lung disease other than COPD, or are receiving cancer treatment.
  • Have exposures that could affect the study, such as smoking in the bedroom, heavy secondhand smoke, e-cigarettes, THC, heavy drug use, alcohol use over 3 ounces a day, or indoor or outdoor pollution.
  • Already use constant oxygen for COPD or air pressure treatment for sleep apnea; have oxygen levels that stay below 89% while awake; or have COPD with blood carbon dioxide above 52 mmHg.
  • Are currently in jail or prison.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (1)

CA