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Clinical trial

Vascular Endothelial Dysfunction in Sleep Apnea

ID
Name
AAAT8810
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).
Trial arms
Trial start
2022-10-03
Estimated PCD
2026-02-28
Trial end
2026-02-28
Status
Recruiting
Phase
Early phase I
Treatment
Atorvastatin 10mg
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.
Arms:
Treatment
Other names:
statin
Placebo
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.
Arms:
Control
Continuous Positive Airway Pressure Therapy
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.
Arms:
Control, Treatment
Other names:
CPAP
Size
110
Primary endpoint
Circulating levels of Angiopoietin-2 after 4 weeks of atorvastatin vs. placebo therapy
4 weeks post-treatment
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
4 weeks post-treatment
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double blind design', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Active drug and placebo will be made identical in appearance and given to participants in a blinded fashion.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2024-02-06

1 organization

1 product

1 drug

1 indication

Organization
Columbia University
Product
Atorvastatin
Indication
Obstructive Sleep Apnea
Drug
Varlilumab