Fatty Liver and Obstructive Sleep Apnea

This study has been completed.

First Received: August 6, 2008 Last Updated: August 7, 2008 History of Changes

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00730873

Purpose

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

Condition	Intervention
Non-Alcoholic Fatty Liver Disease Obstructive Sleep Apnea	Device: Continuous positive airway pressure

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Fatty Liver and Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Liver Diseases Sleep Apnea

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Improved liver enzymes abnormalities [ Time Frame: Within 1-2 years ]

Arms	Assigned Interventions
A: Experimental continuous positive airway pressure	Device: Continuous positive airway pressure

Eligibility

Ages Eligible for Study:	30 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730873

Locations

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

Sponsors and Collaborators

Assaf-Harofeh Medical Center

More Information

No publications provided

Study ID Numbers:	135/07
Study First Received:	August 6, 2008
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00730873 History of Changes
Health Authority:	Israel: Ministry of Health

Study placed in the following topic categories:

Liver Diseases
Sleep Apnea Syndromes
Non-alcoholic Steatohepatitis (NASH)
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders

Dyssomnias
Fatty Liver
Sleep Disorders, Intrinsic
Signs and Symptoms
Digestive System Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Additional relevant MeSH terms:

Liver Diseases
Sleep Apnea Syndromes
Apnea
Nervous System Diseases
Sleep Apnea, Obstructive
Respiration Disorders
Dyssomnias

Sleep Disorders
Fatty Liver
Sleep Disorders, Intrinsic
Signs and Symptoms
Digestive System Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

ClinicalTrials.gov processed this record on July 02, 2009