Investigating the effects of sleep apnea and COPD on heart health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Improving health in patients with COPD and sleep apnea through telehealth lifestyle changes

  This study is testing a telehealth program to see if it can help overweight and obese veterans with COPD and sleep apnea improve their health through lifestyle changes and support.

  Recruiting at 5 sites Seattle Institute for Biomedical and Clinical Research · Boise, Idaho and 4 other locations · NCT06390345

• Effects of Positive Airway Pressure Therapy on Older Veterans with COPD and Sleep Apnea

  This study is testing if positive airway pressure therapy can help older veterans with both COPD and sleep apnea sleep better, feel less tired during the day, and think more clearly compared to standard care.

  Recruiting VA Office of Research and Development · Detroit, Michigan · NCT04179981

• Multimodal Deep Learning to Predict Sleep Apnea Severity from SpO2 and Ballistocardiography

  Researchers are testing a smart-mattress-based method that uses SpO2 and ballistocardiography data to predict sleep apnea severity in adults undergoing overnight sleep study.

  Recruiting Fu Jen Catholic University · New Taipei City, New Taipei City · NCT07923825

• Nightly wearable monitoring with at-home submental electrical stimulation for sleep apnea

  This pilot test checks whether wearing a ring sensor at night and doing a 4-week at-home submental electrical stimulation is feasible for adults with obstructive sleep apnea and looks at changes in sleep metrics.

  Recruiting E-DA Hospital · Kaohsiung City · NCT07921329

• Functional capacity and muscle function in adults with obstructive sleep apnea

  This study tests how obstructive sleep apnea affects respiratory and peripheral muscle strength, endurance, and upper‑extremity function compared with healthy adults.

  Recruiting Karabuk University · Karabük · NCT07913139

• Transcutaneous Electrical Stimulation for Obstructive Sleep Apnea

  This study tests whether applying gentle electrical stimulation to the throat muscles at night can reduce sleep apnea severity in adults with obstructive sleep apnea.

  Recruiting Mansoura University · Al Mansurah, Dakahlia Governorate · NCT07891702

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.