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NCT00730873 Clinical Trial

Fatty Liver and Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:
Fatty Liver and Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00730873
Other study ID # 135/07
Secondary ID
Status Completed
Phase N/A
First received August 6, 2008
Last updated August 7, 2008

Study information
Verified date August 2008
Source Assaf-Harofeh Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 60 Years
Eligibility 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Continuous positive airway pressure

Locations
Country Name City State
Israel The pulmonary institute, Asaf Harofeh Medical Center Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in fatty liver changes on computerized tomography Within 1-2 years
Secondary Improved liver enzymes abnormalities Within 1-2 years
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