RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-13
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05237505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form.
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. * Persons aged 40-79.
  4. * For women, only postmenopausal women will be included
  5. * BMI 20-34 kg/m2 (to allow MRI scanning and to reduce variance).
  6. * 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.
  1. * Premenopausal women (i.e. women are pregnant or may become pregnant) or lactation
  2. * 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.
  3. * Known allergic reactions to components of the study intervention: MRI contrast (gadolinium).
  4. * Concurrent severe sleep disorders (such as periodic limb movements, restless legs syndrome, narcolepsy, idiopathic hypersomnia, etc).
  5. * Exhibit Cheyne-Stokes respiration or central sleep apnea (\> 25 % of events central)
  6. * Take potentially confounding medications or hormones that affect breathing.
  7. * Subjects will be excluded if they are deemed medically unstable with active neurological, cardiac, liver, endocrine, and infectious diseases.
  8. * We will also exclude participants with pulmonary disease apart from COPD.
  9. * We will exclude participants with active cancer treatment.
  10. * We will exclude azotemia (estimated glomerular fraction rate \< 30ml/min) as there is some concern about giving gadolinium to these patients.
  11. * Active smokers (within the past 6 months) or 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).
  12. * Individuals who are already on continuous O2 for COPD or PAP treatment for OSA.
  13. * 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.
  14. * 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.
  15. * COPD individuals with arterial PCO2 higher than 52 mmHg will be excluded.
  16. * Individuals who are currently incarcerated.

Contacts and Locations

Study Contact

Pamela DeYoung, BA
CONTACT
8582462183
pdeyoung@health.ucsd.edu

Principal Investigator

Atul Malhotra, MD
PRINCIPAL_INVESTIGATOR
UCSD

Study Locations (Sites)

UCSD Sleep Research
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Atul Malhotra, MD, PRINCIPAL_INVESTIGATOR, UCSD

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-13
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-02-13
Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

  • OSA
  • obstructive sleep apnea
  • COPD
  • chronic obstructive pulmonary disease
  • PAP therapy
  • oxygen
  • cardiovascular health

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • Chronic Obstructive Pulmonary Disease
  • Overlap Syndrome