NCT00730873

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

First QC Date

August 6, 2008

Last Update Submit

August 7, 2008

Conditions

Non-Alcoholic Fatty Liver DiseaseObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Reduction in fatty liver changes on computerized tomography

    Within 1-2 years

Secondary Outcomes (1)

  • Improved liver enzymes abnormalities

    Within 1-2 years

Study Arms (1)

A

EXPERIMENTAL

continuous positive airway pressure

Device: Continuous positive airway pressure

Interventions

Continuous positive airway pressureDEVICE
A

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The pulmonary institute, Asaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseSleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 6, 2008

First Posted

August 8, 2008

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

IL(1)