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

Overview

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.

Full Title of Study: “Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2019

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: CPAP
    • Subjects in this arm with receive treatment with CPAP for fatty liver disease.
  • Active Comparator: Lifestyle Intervention
    • Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Massachusetts General Hospital
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kathleen E Corey, Instructor in Medicine – Massachusetts General Hospital
  • Overall Official(s)
    • Kathleen E Corey, MD, MPH, Principal Investigator, Massachusetts General Hospital

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