RECRUITING

Vascular Endothelial Dysfunction in Sleep Apnea

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Vascular Endothelial Dysfunction in Sleep Apnea

Quick Facts

Study Start:2022-10-03
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05289063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged ≥18 years
  2. * 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.
  1. * 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
  2. * Regular use of any medications

Contacts and Locations

Study Contact

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

Principal Investigator

Sanja Jelic, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Sanja Jelic, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-03
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-10-03
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

  • CPAP
  • Atorvastatin

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea of Adult