Back to resultsFatty Liver and Obstructive Sleep Apnea
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Continuous positive airway pressure
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease
Eligibility Criteria
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
Sites / Locations
- The pulmonary institute, Asaf Harofeh Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
continuous positive airway pressure
Outcomes
Primary Outcome Measures
Reduction in fatty liver changes on computerized tomography
Secondary Outcome Measures
Improved liver enzymes abnormalities
Full Information
NCT ID
NCT00730873
First Posted
August 6, 2008
Last Updated
August 7, 2008
Sponsor
Assaf-Harofeh Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00730873
Brief Title
Fatty Liver and Obstructive Sleep Apnea
Official Title
Fatty Liver and Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Assaf-Harofeh Medical Center
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
continuous positive airway pressure
Intervention Type
Device
Intervention Name(s)
Continuous positive airway pressure
Primary Outcome Measure Information:
Title
Reduction in fatty liver changes on computerized tomography
Time Frame
Within 1-2 years
Secondary Outcome Measure Information:
Title
Improved liver enzymes abnormalities
Time Frame
Within 1-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The pulmonary institute, Asaf Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
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Fatty Liver and Obstructive Sleep Apnea
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