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.
Full Title of Study: “Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2019
- Device: CPAP
- Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.
- Behavioral: LIfestyle
- Subjects will undergo 12 weeks of dietary counseling.
Arms, Groups and Cohorts
- Experimental: CPAP
- Subjects in this arm with receive treatment with CPAP for fatty liver disease.
- Active Comparator: Lifestyle Intervention
- Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
Clinical Trial Outcome Measures
- Steatosis by MRS
- Time Frame: 12 weeks
- Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.
Participating in This Clinical Trial
- 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. Exclusion Criteria:
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Massachusetts General Hospital
- National Institutes of Health (NIH)
- Provider of Information About this Clinical Study
- Principal Investigator: Kathleen E Corey, Instructor in Medicine – Massachusetts General Hospital
- Overall Official(s)
- Kathleen E Corey, MD, MPH, Principal Investigator, Massachusetts General Hospital
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