Investigating the effects of sleep apnea and COPD on heart health
The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
This study is testing how having both sleep apnea and COPD affects heart health and whether a specific breathing treatment works better than oxygen therapy for improving heart outcomes in these patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 40 Years to 79 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT05237505 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the cardiovascular risks associated with the overlap syndrome of obstructive sleep apnea (OSA) and chronic obstructive pulmonary disease (COPD). It will involve a cross-sectional analysis comparing vascular risk markers in individuals with OSA, COPD, and those with both conditions. Additionally, a randomized clinical trial will assess the effectiveness of bi-level positive airway pressure (PAP) therapy versus oxygen therapy in improving cardiovascular outcomes in patients with overlap syndrome. Participants will undergo eligibility screening, in-person assessments, and treatment interventions to evaluate their health outcomes.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women and men aged 40-79 diagnosed with untreated moderate to severe obstructive sleep apnea and/or chronic obstructive pulmonary disease.
Not a fit: Patients who are premenopausal women or those with specific cardiac devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from both sleep apnea and COPD, potentially reducing cardiovascular risks.
How similar studies have performed: While studies have explored aspects of OSA and COPD separately, this specific overlap syndrome approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California
- UCSD Sleep Research — La Jolla, California, United States (Recruiting)
Study contacts
- Principal investigator: Atul Malhotra, MD — UCSD
- Study coordinator: Pamela DeYoung, BA
- Email: pdeyoung@health.ucsd.edu
- Phone: 8582462183
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.