Vascular Endothelial Dysfunction in Sleep Apnea

Columbia University

Status and phase: Enrolling; Phase 1

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Drug: Atorvastatin 10mg; Drug: Placebo; Other: Continuous Positive Airway Pressure Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05289063

AAAT8810

2R01HL106041 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 2 patient groups, including a placebo group

Treatment

Active Comparator group

Description:

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

Treatment:

Other: Continuous Positive Airway Pressure Therapy

Drug: Atorvastatin 10mg

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Continuous Positive Airway Pressure Therapy

Drug: Placebo