Vascular Endothelial Dysfunction in Sleep Apnea
Key facts
- Who runs it
- Columbia University
- Where
- New York, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 110 people, planned
- Started
- 3 Oct 2022
- Expected to end
- 28 Feb 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Atorvastatin 10mg
- Placebo
- Continuous Positive Airway Pressure Therapy
- Record updated
- 13 February 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Regular use of any medications
- 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
Where in United States
- Columbia University Irving Medical CenterNew York, United StatesContact: Sanja Jelic, MDTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- TreatmentExisting treatment, for comparison
OSA patients who adhered or did not adhere with CPAP who are randomized to receive atorvastatin 10 mg daily.
Treatment: Atorvastatin 10mg and Continuous Positive Airway Pressure Therapy
- ControlPlacebo, for comparison
OSA patients who adhered or did not adhere with CPAP who are randomized to receive placebo daily.
Treatment: Placebo and Continuous Positive Airway Pressure Therapy
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 13 February 2026