Status:
WITHDRAWN
Evaluating the Efficacy of CPAP Therapy for the Treatment of Fatty Liver
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Non-alcoholic Fatty Liver Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01849081
Start Date
March 1 2019
End Date
March 1 2019
Last Update
October 6 2020
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114