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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01849081
Recruitment Status : Withdrawn (Change in priorities, study closed prior to enrollment)
First Posted : May 8, 2013
Last Update Posted : October 6, 2020
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kathleen E Corey, Massachusetts General Hospital

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 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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Device: CPAP Behavioral: LIfestyle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Efficacy of CPAP Therapy for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD)
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
Experimental: CPAP
Subjects in this arm with receive treatment with CPAP for fatty liver disease.
Device: CPAP
Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.

Active Comparator: Lifestyle Intervention
Subjects in the lifestyle arm will undergo 12 weeks of dietary counseling.
Behavioral: LIfestyle
Subjects will undergo 12 weeks of dietary counseling.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01849081

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institutes of Health (NIH)
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Principal Investigator: Kathleen E Corey, MD, MPH Massachusetts General Hospital
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Responsible Party: Kathleen E Corey, Instructor in Medicine, Massachusetts General Hospital Identifier: NCT01849081    
Other Study ID Numbers: 2013P000688
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kathleen E Corey, Massachusetts General Hospital:
Non-alcoholic fatty liver disease
Obstructive sleep apnea
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases