The purpose of this study is to test whether Spironolactone can improve the severity of obstructive sleep apnea and improve cardiovascular biomarkers in people who are not regularly using their Positive Airway Pressure (PAP) therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
If tolerated and serum potassium \<5.0 meq/L, the dose will be increased to 50 mg (2 pills) after 4 weeks. If serum potassium is \>5.0 but less than 5.5 or creatinine \>4.0 mg/dL, the dose will be adjusted to 25 mg every other day; if potassium levels ≥5.5 in a non-hemolyzed blood sample, the medication will be discontinued.
Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.
The University of Michigan
Ann Arbor, Michigan, United States
Change in apnea-hypopnea index (AHI)
AHI is obtained from polysomnography studies
Time frame: Day 0, Day 84
Change in minimum oxygen saturation (SaO2)
Oxygen saturation is obtained from polysomnography studies
Time frame: Day 0, Day 84
Change in Inflammatory biomarker
Biomarkers of interest will be obtained via blood draws. Markers of interest: Interleukin 6 protein (IL-6), Tumor necrosis factor alpha (TNF α), High Sensitivity C-Reactive Protein, Brain Natriuretic Peptide (BNP), and procollagen 1 and 3.
Time frame: Day 0, Day 84
Change in Diurnal blood pressure
Measured using SPRINT methods; Seated blood pressure is measured after a rest period using an automated device or manual devices if necessary. The preferred method is the automated device. Both systolic and diastolic blood pressure will be measured.
Time frame: Day 0, Day 84
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