Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver

Massachusetts General Hospital

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

CPAPDEVICE

Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.

LIfestyleBEHAVIORAL

Subjects will undergo 12 weeks of dietary counseling.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Steatosis by MRS

Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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