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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152711
First Posted: September 9, 2005
Last Update Posted: February 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Angers
  Purpose
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.

Condition Intervention
Sleep Apnea Syndrome Nonalcoholic Steatohepatitis Device: nCPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis: A Prospective Cross Over Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 40
Study Start Date: September 2004
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152711


Contacts
Contact: Frédéric Gagnadoux, MD 33(0)241353695 frgagnadoux@chu-angers.fr

Locations
France
University Hospital Angers Recruiting
Angers, France
Contact: Frédéric Gagnadoux, MD    33(0)241353695    frgagnadoux@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Frédéric Gagnadoux UH Angers
  More Information

ClinicalTrials.gov Identifier: NCT00152711     History of Changes
Other Study ID Numbers: PHRC 03-07
First Submitted: September 8, 2005
First Posted: September 9, 2005
Last Update Posted: February 13, 2007
Last Verified: September 2005

Additional relevant MeSH terms:
Syndrome
Apnea
Sleep Apnea Syndromes
Fatty Liver
Non-alcoholic Fatty Liver Disease
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Liver Diseases
Digestive System Diseases