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
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in apnea-hypopnea index (AHI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
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"]) .
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Spironolactone
Dose of 25 mg daily that may be titrated up to 50 mg daily, if tolerated and will receive treatment as usual for obstructive sleep apnea.
干预措施: Spironolactone (Drug)
Placebo
Placebo and will receive treatment as usual for obstructive sleep apnea.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in apnea-hypopnea index (AHI)
时间窗: Day 0, Day 84
AHI is obtained from polysomnography studies
次要结局
- Change in minimum oxygen saturation (SaO2)(Day 0, Day 84)
- Change in Inflammatory biomarker(Day 0, Day 84)
- Change in Diurnal blood pressure(Day 0, Day 84)
研究者
Louise O'Brien
Research Associate Professor, Neurology, Research Associate Professor, Obstetrics and Gynecology, Medical School and Associate Research Scientist, Dentistry, Department of Oral and Maxillofacial Surgery, School of Dentistry
University of Michigan