Fatty Liver and Obstructive Sleep Apnea

August 7, 2008 updated by: Assaf-Harofeh Medical Center
Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel, 70300
        • The pulmonary institute, Asaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obstructive sleep apnea, defined as AHI>5/h

Exclusion Criteria:

  • Consumption of more than 20 grams of alcohol per 24 h
  • Known autoimmune disease
  • Usage of known hepatotoxic drugs
  • Medical history positive for viral hepatitis or other chronic liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
continuous positive airway pressure
Device: Continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in fatty liver changes on computerized tomography
Time Frame: Within 1-2 years
Within 1-2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improved liver enzymes abnormalities
Time Frame: Within 1-2 years
Within 1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 6, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (Estimate)

August 8, 2008

Study Record Updates

Last Update Posted (Estimate)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 135/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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