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

NCT ID: NCT00152711

Last Updated: 2007-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Brief Summary

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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

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Conditions

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Sleep Apnea Syndrome Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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nCPAP

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Frédéric Gagnadoux

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Locations

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University Hospital Angers

Angers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédéric Gagnadoux, MD

Role: CONTACT

33(0)241353695

Facility Contacts

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Frédéric Gagnadoux, MD

Role: primary

33(0)241353695

Other Identifiers

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PHRC 03-07

Identifier Type: -

Identifier Source: org_study_id

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