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Obstructive Sleep Apnea of AdultPhase 1NCT05289063

Vascular Endothelial Dysfunction in Sleep Apnea

A Phase 1 study testing Atorvastatin 10mg and Continuous Positive Airway Pressure Therapy in people with Obstructive Sleep Apnea of Adult, run by Columbia University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea of Adult
What is being tested?
Atorvastatin 10mg and Continuous Positive Airway Pressure Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteUnited States
Study dates
3 Oct 2022to 28 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
  • Regular use of any medications

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sanja Jelic, MD contact

2125438875

sj366@cumc.columbia.edu

United States1 site, 1 recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Sanja Jelic, MD, 212-543-8875, sj366@cumc.columbia.edu

    Sanja Jelic, MD

    Recruiting

Other trials in United States

About this study

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).

Read the detailed description

Obstructive sleep apnea (OSA), a condition that affects a quarter of American adults, triples the risk for cardiovascular diseases and increases all-cause mortality. Standard therapy with continuous positive airway pressure (CPAP) does not improve cardiovascular risk. Based on the investigators' mechanistic observation that the abnormal cycle of endothelial inflammation can be disrupted with statin therapy, the investigators now propose randomized clinical trial of statins vs. placebo to determine its effects on endothelial dysfunction in OSA patients treated with CPAP, which may provide the basis for practical clinical trials of statins for reducing cardiovascular risk in OSA.

Being tested
Atorvastatin 10mg, Placebo, Continuous Positive Airway Pressure Therapy
Keywords
CPAP, Atorvastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atorvastatin 10mgDrug

    Also called statin

    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.

  • PlaceboDrug

    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 TherapyOther

    Also called CPAP

    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 groups in NCT05289063
Study groupRoleWhat they receive
TreatmentActive comparatorOSA patients who adhered or did not adhere with CPAP who are randomized to receive atorvastatin 10 mg daily.
Receives: Drug: Atorvastatin 10mg; Other: Continuous Positive Airway Pressure Therapy
ControlPlacebo comparatorOSA patients who adhered or did not adhere with CPAP who are randomized to receive placebo daily.
Receives: Drug: Placebo; Other: Continuous Positive Airway Pressure Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy

    Mean circulating levels of Ang-2 will be quantified after 4 weeks of statin or placebo therapy by enzyme-linked immunosorbent assay (ELISA)

    Measured: 4 weeks post-treatment

  2. Interaction of endoplasmic reticulum (ER)-bound vesicle-associated membrane protein-associated protein B (VAPB) with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) after 4 weeks of atorvastatin vs. placebo therapy

    Mean Interactions ER-bound VAPB with late endosome-bound ORP1L in harvested endothelial cells (ECs) will be assessed using proximity ligation assay (DuoLink, fluorescence area in µm2) after 4 weeks of atorvastatin or placebo therapy

    Measured: 4 weeks post-treatment

Secondary outcomes (10)

  1. Circulating levels of von Willebrand factor cleavage products after 4 weeks of atorvastatin vs. placebo

    Mean Circulating levels (count) of von Willebrand factor (vWF) cleavage products (low molecular weight (LMW), medium molecular weight (IMW), high molecular weight (HMW)) after 4 weeks of atorvastatin vs. placebo

    Measured: 4 weeks post-treatment

  2. Circulating levels of von Willebrand factor (vWF) cleavage products (low, medium, high molecular weight) at baseline and after 4 weeks of CPAP

    Mean Circulating levels (count) of vWF cleavage products (LMW, IMW, HMW) at baseline and after CPAP.

    Measured: 4 weeks post-CPAP

  3. Endothelial cell free cholesterol levels after 4 weeks of atorvastatin vs. placebo

    Mean Endothelial cell free cholesterol levels (fluorescence intensity) after 4 weeks of atorvastatin vs. placebo therapy

    Measured: 4 weeks post-treatment

  4. Endothelial cell lipid droplets after 4 weeks of atorvastatin vs. placebo

    Mean Endothelial cell lipid droplets (fluorescence area µm2) after 4 weeks of atorvastatin vs. placebo

    Measured: 4 weeks post-treatment

  5. Endothelial cell interactions between CD59 and Weibel Palade Bodies (WPBs) after 4 weeks of atorvastatin vs. placebo

    Mean Endothelial cell interactions between CD59 and Weibel Palade Bodies (fluorescence area µm2) after 4 weeks of atorvastatin vs. placebo

    Measured: 4 weeks post-treatment

  6. Circulating levels of Angiopoietin-2 at baseline and after 4 weeks of CPAP therapy

    Mean Circulating levels of Angiopoietin-2 after 4 weeks of CPAP therapy quantified by ELISA

    Measured: 4 weeks post-CPAP

  7. Interaction of ER-bound VAPB with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) at baseline and after 4 weeks of CPAP therapy

    Mean Interaction of ER-bound VAPB with late endosome-bound ORP1L (proximity ligation assay fluorescence area in µm2) after 4 weeks of CPAP therapy

    Measured: 4 weeks post-CPAP

  8. Endothelial cell nuclear factor kappa B (NF-κB) nuclear fluorescence intensity after 4 weeks of atorvastatin vs. placebo

    Mean Endothelial cell NF-kB nuclear fluorescence intensity after 4 weeks of atorvastatin vs. placebo

    Measured: 4 weeks post-treatment

  9. Circulating levels of E-selectin after 4 weeks of atorvastatin vs. placebo therapy

    Mean Circulating levels of E-selectin after 4 weeks of atorvastatin vs. placebo therapy quantified by ELISA

    Measured: 4 weeks post-treatment

  10. Endothelial cell messenger ribonucleic acid (mRNA) expression of EC adhesion molecules after 4 weeks of atorvastatin vs. placebo

    Mean Endothelial cell mRNA expression of EC adhesion molecules after 4 weeks of atorvastatin vs. placebo quantified by reverse transcription polymerase chain reaction (RT-PCR)

    Measured: 4 weeks post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2022
  2. Study start3 Oct 2022
  3. Primary completion28 Feb 2027 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized double blind design
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05289063
Sponsor's protocol ID
AAAT8810
Other IDs
2R01HL106041
Status last verified
Feb 2026
First submitted
10 Mar 2022
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atorvastatin 10mg and Continuous Positive Airway Pressure Therapy in people with Obstructive Sleep Apnea of Adult, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sanja Jelic, MD (2125438875, sj366@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy (time frame: 4 weeks post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05289063.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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