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

Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01849081

Enrollment

Registered

2013-05-08

Start date

2019-03-31

Completion date

2019-03-31

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Non-alcoholic fatty liver disease, Obstructive sleep apnea

Brief summary

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.

Interventions

DEVICECPAP

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

BEHAVIORALLIfestyle

Subjects will undergo 12 weeks of dietary counseling.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Steatosis by MRS	12 weeks	Subjects will undergo baseline and 12 week magnetic resonance spectroscopy to assess the impact of CPAP or diet on fatty liver.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026