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NCT05237505 · ClinicalTrials.gov registry record · Phase 2
The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)
A Phase 2 study of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT05237505 is a Phase 2 study of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 240 participants, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target. The trial reports 1 study location across 1 state.
The verdict
NCT05237505, a Phase 2 study of Obstructive Sleep Apnea and Chronic Obstructive Pulmonary Disease, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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 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 mechanis
Conditions Studied
Interventions
- DEVICE bi-level positive pressure non invasive ventilation
- DRUG Oxygen gas
Study Locations (1)
California
- UCSD Sleep Research - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-02-13 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05237505
The ClinicalTrials.gov registry entry for NCT05237505 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which bi-level positive pressure non invasive ventilation is the first listed.
NCT05237505 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05237505 about?
NCT05237505 is a clinical study titled "The Cardiovascular Consequences of Sleep Apnea Plus COPD (Overlap Syndrome)". 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 C...
What is the current status of trial NCT05237505?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2024-02-13. Estimated completion is 2028-08-31.
What conditions does trial NCT05237505 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea, Chronic Obstructive Pulmonary Disease, Overlap Syndrome.
What interventions are being tested in trial NCT05237505?
The interventions under investigation include: bi-level positive pressure non invasive ventilation (DEVICE), Oxygen gas (DRUG).
Who is sponsoring clinical trial NCT05237505?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05237505 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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