Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Steatosis by MRS
研究概览
简要总结
We are doing this research study to evaluate whether continuous positive airway pressure (CPAP), a treatment for sleep apnea, will also help treat fatty liver disease. Sleep apnea is a disease where a person has interruptions in their breathing while they are sleep. This can lead to low oxygen levels in the blood. CPAP is a mask that delivers oxygen at high pressure to the lungs to prevent a decrease in blood oxygen levels. CPAP is a known treatment for sleep apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older with a previous liver biopsy showing NASH and at least grade 2 steatosis
- •Obstructive sleep apnea diagnosed by sleep study.
排除标准
- •Other causes of chronic liver disease
- •cirrhosis
- •less than 33% steatosis identified on magnetic resonance spectroscopy (MRS)
- •Alcohol use >2 units per day for women or >3 units per day for men
- •Intolerance to or refusal of CPAP therapy
- •overnight desaturation (more than 10% of the sleep time with oxygen desaturation below 85%)
- •underlying sever sleepiness (Epworth scale more than 15)
- •uncontrolled hypertension
- •Severe heart failure (ejection fracture less than 30%)
- •cardiac arrhythmias (atrial fibrillation or history of ventricular tachycardia)
- •those who are commercial drivers
研究组 & 干预措施
CPAP
Subjects in this arm with receive treatment with CPAP for fatty liver disease.
干预措施: CPAP (Device)
Lifestyle Intervention
Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
干预措施: LIfestyle (Behavioral)
结局指标
主要结局
Steatosis by MRS
时间窗: 12 weeks
Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
次要结局
未报告次要终点
研究者
Kathleen E Corey
Instructor in Medicine
Massachusetts General Hospital