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

University of Michigan

Status and phase

Withdrawn

Phase 4

Conditions

Obstructive Sleep Apnea

Treatments

Drug: Placebo

Drug: Spironolactone

Study type

Interventional

Funder types

Other

Identifiers

NCT04205136

HUM00147375

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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