NCT00152711

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.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

February 13, 2007

Status Verified

September 1, 2005

First QC Date

September 8, 2005

Last Update Submit

February 12, 2007

Conditions

Sleep Apnea SyndromeNonalcoholic Steatohepatitis

Interventions

nCPAPDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychiatric disorder
  • Other cause of liver disease
  • Professional driver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Angers

Angers, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Frédéric Gagnadoux

    UH Angers

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédéric Gagnadoux, MD

CONTACT

33(0)241353695frgagnadoux@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

September 1, 2004

Last Updated

February 13, 2007

Record last verified: 2005-09

Locations

FR(1)