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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP

Subjects in this arm with receive treatment with CPAP for fatty liver disease.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

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

Lifestyle Intervention

Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.

Group Type ACTIVE_COMPARATOR

LIfestyle

Intervention Type BEHAVIORAL

Subjects will undergo 12 weeks of dietary counseling.

Interventions

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CPAP

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

Intervention Type DEVICE

LIfestyle

Subjects will undergo 12 weeks of dietary counseling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No