Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients

• Status: Not yet recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Spironolactone

Criteria

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