Impact of nCPAP Treatment on Liver Function in Patients W... | NCT00152711

Studies
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis

NCT00152711

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Feb 13, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Sleep Apnea Syndrome
Nonalcoholic Steatohepatitis

Interventions

nCPAP

Countries

France

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

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 9, 2005Estimated

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

Feb 12, 2007

Last Update Posted Date

Feb 13, 2007Estimated

Description Module

Brief Summary

This study aims to evaluate the impact of nasal continuous positive airway pressure (nCPAP) treatment on liver enzymes in patients with sleep apnea syndrome and nonalcoholic steatohepatitis. Using a cross over design, the evolution of liver enzymes will be evaluated in 40 patients during a consecutive period of 6 weeks, with and without nCPAP treatment.

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

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
nCPAP	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 to 70 years old
Nonalcoholic steatohepatitis proven by liver biopsy
Sleep apnea syndrome proven by polysomnography with an apnea-hypopnea index > 10 events/hour
Informed consent

Exclusion Criteria:

Psychiatric disorder
Other cause of liver disease
Professional driver

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Frédéric Gagnadoux, MD	Contact	33(0)241353695		frgagnadoux@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Frédéric Gagnadoux	UH Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Angers	Recruiting	Angers			France

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D065626	Non-alcoholic Fatty Liver Disease

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

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