Obstructive Sleep Apnea
Conditions
Keywords
Spironolactone, Positive Airway Pressure
Brief summary
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.
Interventions
DRUGSpironolactone
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.
DRUGPlacebo
Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Both groups will receive treatment as usual for obstructive sleep apnea. Spironolactone and placebo will be prescribed by one of the study physicians (who will not be blinded to treatment condition \[care provider\]) .
Intervention model description
The researchers will do a trial of spironolactone in 30 obstructive sleep apnea (OSA) patients with cardiovascular disease who are non-adherent with Positive Airway Pressure (PAP) therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Body Mass Index (BMI) greater than or equal to 30 * Diagnosis of moderate to severe OSA via diagnostic polysomnography (AHI≥15) or home sleep apnea test (respiratory event index (REI)≥15). * Diagnosis of cardiovascular disease * Meet criteria for hypertension (minimum systolic blood pressure ≥ 140 but \<180) * Prescribed PAP therapy but non-adherent (failure to use PAP for at least 4 hours per night on minimum 5/7 nights per week on average over a one-month period)
Exclusion criteria
* Diagnosis of congestive heart failure; resistant hypertension; hepatic disease; Addison's disease; cancer; or recent (past 3 months) myocardial infarction, or stroke * Diagnosis of central sleep apnea * Patients who are not using PAP at all (untreated) or using another form of treatment for OSA * Currently taking, recent trial (past month), or allergy for spironolactone * Severe respiratory disease (e.g., diagnosis of chronic obstructive pulmonary disease, uncontrolled asthma) * History of leukopenia and/or thrombocytopenia * Current use of another potassium sparing diuretic (e.g., amiloride or eplerenone) * Current use of lithium, barbiturates, narcotics, muscle relaxants, pressor amines, or cholestyramine * Patients who plan to have surgery during the time period of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in apnea-hypopnea index (AHI) | Day 0, Day 84 | AHI is obtained from polysomnography studies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in minimum oxygen saturation (SaO2) | Day 0, Day 84 | Oxygen saturation is obtained from polysomnography studies |
| Change in Inflammatory biomarker | Day 0, Day 84 | 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. |
| Change in Diurnal blood pressure | Day 0, Day 84 | 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. |
Countries
United States
Outcome results
None listed