Status:
RECRUITING
The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
Lead Sponsor:
University of California, San Diego
Conditions:
Obstructive Sleep Apnea
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-79 years
Phase:
PHASE2
Brief Summary
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 obstruc...
Detailed Description
For Aim 1, we will perform a cross-sectional clinical study that will allow us to test the hypothesis that individuals with OVS have increased markers of vascular risk compared with matched individual...
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.
Key Trial Info
Start Date :
February 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05237505
Start Date
February 13 2024
End Date
August 31 2028
Last Update
December 17 2025
Active Locations (1)
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1
UCSD Sleep Research
La Jolla, California, United States, 92037