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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 because the information has not been verified recently.
Verified September 2005 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00152711
First received: September 8, 2005
Last updated: February 12, 2007
Last verified: September 2005
History of Changes
  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: 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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by University Hospital, Angers:

Estimated Enrollment: 40
Study Start Date: September 2004
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00152711     History of Changes
Other Study ID Numbers: PHRC 03-07
Study First Received: September 8, 2005
Last Updated: February 12, 2007
Health Authority: France: French General Health Administration

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Fatty Liver
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013