Double breathing trouble: study tests two therapies to protect hearts
NCT ID NCT05237505
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how having both sleep apnea and COPD (called overlap syndrome) affects the heart. Researchers will compare people with one or both conditions and test two breathing treatments—a special mask that helps breathing at night and extra oxygen—to see which may improve heart health. The goal is to understand why people with both conditions are at higher risk for heart problems and find better ways to help them.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bi-level positive pressure non invasive ventilation (BIPAP) and nocturnal oxygen therapy
- What this could lead to
- If successful, this study could point toward better heart treatments for people with both sleep apnea and COPD.
- What could go wrong
- This is an early phase 2 pilot study with only 240 participants, so results may not apply to everyone. The treatments may not show clear heart benefits.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Locations
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UCSD Sleep Research
RECRUITINGLa Jolla, California, 92037, United States
Contact Email: •••••@•••••
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