Fatty Liver and Obstructive Sleep Apnea | NCT00730873

Studies
Fatty Liver and Obstructive Sleep Apnea

NCT00730873

Sponsor

Assaf-Harofeh Medical Center

Status

Completed

Last Update Posted

Aug 8, 2008Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Non-Alcoholic Fatty Liver Disease
Obstructive Sleep Apnea

Interventions

Continuous positive airway pressure

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 6, 2008

First Submission Date that Met QC Criteria

Aug 7, 2008

First Posted Date

Aug 8, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2008

Last Update Posted Date

Aug 8, 2008Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	continuous positive airway pressure	Device: Continuous positive airway pressure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Continuous positive airway pressure	Device		A

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The pulmonary institute, Asaf Harofeh Medical Center		Ẕerifin		70300	Israel

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases
D012891	Sleep Apnea Syndromes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D045422	Continuous Positive Airway Pressure

Ancestor Terms

ID	Term
D011175	Positive-Pressure Respiration
D012121	Respiration, Artificial
D058109	Airway Management
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided