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Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients | Clinical Trials | Clareo Health

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

Spironolactone to Improve Apnea and Cardiovascular Markers in Obstructive Sleep Apnea Patients With Cardiovascular Disease Who Are Non-Adherent With Positive Airway Pressure: A Randomized Placebo-Controlled Pilot Trial

NCT04205136•University of Michigan

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 85 years

Sex

ALL

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

Locations (1)

The University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

March 1, 2022

Primary Completion Date

April 1, 2023

Completion Date

April 1, 2023

Last Updated

April 19, 2022

Conditions

Obstructive Sleep Apnea

Interventions

Spironolactone

DRUG

Placebo

DRUG

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NCT06430957

Obstructive Sleep Apnea Risk ManagementPostoperative Complications+2 more

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RECRUITINGNA

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Obstructive Sleep Apnea (OSA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea

Diaphragm Ultrasound İn Children With OSAS

BodySleep Algorithm for OSA Diagnosis in Children