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

Mass General Brigham

Status

Withdrawn

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Behavioral: LIfestyle

Device: CPAP

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01849081

2013P000688

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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