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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 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.

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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).

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

FieldValue
Enrollment Target 110 participants
Start Date 2022-10-03
Est. Completion 2027-02-28
Phase Phase 1

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT05289063

The ClinicalTrials.gov registry entry for NCT05289063 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 511-participant average among 8 other Obstructive Sleep Apnea of Adult trials with a reported enrollment target (78% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.