Recruiting
Phase 1

Observational Study

Sponsor:

Columbia University

Code:

NCT05289063

Conditions

Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Atorvastatin 10mg

Placebo

Continuous Positive Airway Pressure Therapy

Study Details

Brief 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).

Conditions

Obstructive Sleep Apnea of Adult

Study ID

NCT05289063

Start date

Oct 3, 2022

Status verified date

Feb, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged ≥18 years
  • Newly diagnosed with obstructive sleep apnea (OSA) who were never treated with CPAP. OSA is defined as apnea-hypopnea index (AHI) ≥5 events/hour of sleep.

Exclusion Criteria:

  • A history of coronary artery disease, heart failure, stroke, diabetes, malignancy, chronic pulmonary, kidney or rheumatologic disease, muscle pain/fatigue, smoking within the past 5 years
  • Regular use of any medications

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Treatment

OSA patients who adhered or did not adhere with CPAP who are randomized to receive atorvastatin 10 mg daily.

placebo comparator: Control

OSA patients who adhered or did not adhere with CPAP who are randomized to receive placebo daily.

Interventions

Atorvastatin 10mg

Atorvastatin 10 mg daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.

Placebo

Placebo daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.

Continuous Positive Airway Pressure Therapy

CPAP is a standard of care for OSA and will be prescribed by care providers not associated with this study based on clinical indications. The investigators will have no role in prescribing CPAP.

Primary outcome measure

  • Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy [ Time Frame: 4 weeks post-treatment ]
  • Interaction of endoplasmic reticulum (ER)-bound vesicle-associated membrane protein-associated protein B (VAPB) with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) after 4 weeks of atorvastatin vs. placebo therapy [ Time Frame: 4 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Sanja Jelic, MD

2125438875sj366@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Sanja Jelic, MD

212-543-8875sj366@cumc.columbia.edu

Principal Investigator:

Sanja Jelic, MD

More Information

Sponsor

Columbia University

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • CPAP
  • Atorvastatin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-13.