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



Status:Not yet recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:July 2016
End Date:July 2018

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

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.


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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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