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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01849081
• Other study ID #: 2013P000688
• Status: Withdrawn
• Phase: N/A
• Start date: March 2019
• Est. completion date: March 2019

Study information

• Verified date: October 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

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

Behavioral:
• LIfestyle
Subjects will undergo 12 weeks of dietary counseling.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

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