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NCT05289063 · ClinicalTrials.gov registry record · Phase 1
Vascular Endothelial Dysfunction in Sleep Apnea
A Phase 1 study of Obstructive Sleep Apnea of Adult, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT05289063: Recruiting Phase 1 study of Obstructive Sleep Apnea of Adult, sponsored by Columbia University.
NCT05289063 is a Phase 1 study of Obstructive Sleep Apnea of Adult that is actively recruiting participants, run by Columbia University. The registered enrollment target is 110 participants, below the 511-participant average among 8 other Obstructive Sleep Apnea of Adult trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05289063, a Phase 1 study of Obstructive Sleep Apnea of Adult, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
This double-blind placebo-controlled parallel group randomized study design will be used to test whether 4 weeks of atorvastatin 10 mg daily reduces levels of inflammatory markers in OSA patients treated with CPAP (standard of care). The purpose of this study is to investigate: 1) whether statins reduce endothelial inflammation and pro-thrombotic conditions in OSA, including in patients adherent to CPAP (Aim 1); and 2) whether statins reduce endothelial inflammation and pro-thrombotic conditions by improving endothelial cholesterol metabolism and trafficking in OSA (Aim 2).
Primary Outcome
Mean circulating levels of Ang-2 will be quantified after 4 weeks of statin or placebo therapy by enzyme-linked immunosorbent assay (ELISA)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Atorvastatin 10mg
- OTHER Continuous Positive Airway Pressure Therapy
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 1 |
What NCT05289063 shows while recruiting
NCT05289063 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 511-participant average among 8 other Obstructive Sleep Apnea of Adult trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Obstructive Sleep Apnea of Adult appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05289063 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05289063 about?
NCT05289063 is a clinical study titled "Vascular Endothelial Dysfunction in Sleep Apnea". This double-blind placebo-controlled parallel group randomized study design will be used to test whether 4 weeks of atorvastatin 10 mg daily reduces levels of inflammatory markers in OSA patients treated with CPAP (standard of care). The purpose of this study is to investigate: 1) whether statins re...
What is the current status of trial NCT05289063?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2022-10-03. Estimated completion is 2027-02-28.
What conditions does trial NCT05289063 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea of Adult.
What interventions are being tested in trial NCT05289063?
The interventions under investigation include: Placebo (DRUG), Atorvastatin 10mg (DRUG), Continuous Positive Airway Pressure Therapy (OTHER).
Who is sponsoring clinical trial NCT05289063?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05289063 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obstructive Sleep Apnea of Adult
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05289063's enrollment target sits among peer trials
110 7th of 8 higher than 2 of 8 other Obstructive Sleep Apnea of Adult trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea of Adult trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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