Vascular Endothelial Dysfunction in Sleep Apnea

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Columbia University Irving Medical Center
RECRUITING
New York
Contact Information
Primary
Sanja Jelic, MD
sj366@cumc.columbia.edu
2125438875
Time Frame
Start Date: 2022-10-03
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 110
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov