Trials Today

Vascular Endothelial Dysfunction in Sleep Apnea

Purpose

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).

Condition

Obstructive Sleep Apnea of Adult

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: Phase 1
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized double blind design
Primary Purpose: Basic Science
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Active drug and placebo will be made identical in appearance and given to participants in a blinded fashion.

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Treatment	OSA patients who adhered or did not adhere with CPAP who are randomized to receive atorvastatin 10 mg daily.	Drug: 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. Other names: statin Other: 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. Other names: CPAP
Placebo Comparator Control	OSA patients who adhered or did not adhere with CPAP who are randomized to receive placebo daily.	Drug: 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. Other: 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. Other names: CPAP

Recruiting Locations

Columbia University Irving Medical Center
New York, New York 10032

Contact:
Sanja Jelic, MD
212-543-8875
sj366@cumc.columbia.edu

More Details

NCT ID: NCT05289063
Status: Recruiting
Sponsor: Columbia University

Study Contact

Sanja Jelic, MD
2125438875
sj366@cumc.columbia.edu

Detailed Description

Obstructive sleep apnea (OSA), a condition that affects a quarter of American adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Standard therapy with continuous positive airway pressure (CPAP) does not improve cardiovascular risk. Based on the investigators' mechanistic observation that the abnormal cycle of endothelial inflammation can be disrupted with statin therapy, the investigators now propose randomized clinical trial of statins vs. placebo to determine its effects on endothelial dysfunction in OSA patients treated with CPAP, which may provide the basis for practical clinical trials of statins for reducing cardiovascular risk in OSA.