Vascular Endothelial Dysfunction in Sleep Apnea

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT05289063
Phase
PHASE1
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atorvastatin 10mg — 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 — 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 — 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

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).

Key Dates

Start date
Oct 3, 2022
Status verified
Feb 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy [ Time Frame: 4 weeks post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Sanja Jelic, MD
[email protected]
212-543-8875
Sanja Jelic, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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