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Obstructive Sleep Apnea of AdultSleepDrugPhase 1

What this study is

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).

What's being tested

  • Atorvastatin 10mg

    Intervention · DRUG

    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

    Intervention · DRUG

    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

    Intervention · OTHER

    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.

Study details

Sponsor
Columbia University
Conditions
Obstructive Sleep Apnea of Adult
Enrolling
110 people
Starts
2022-10-03
Est. completion
2027-02-28
Design
Quadruple-blind, randomized, parallel groups, Phase 1
Record
View on ClinicalTrials.gov ↗