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

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ClinicalTrials.gov Identifier: NCT00152711
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 9, 2005
Last Update Posted : February 13, 2007
Sponsor:
Information provided by:
University Hospital, Angers

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Nonalcoholic Steatohepatitis Device: nCPAP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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
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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
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ClinicalTrials.gov Identifier: NCT00152711     History of Changes
Other Study ID Numbers: PHRC 03-07
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: February 13, 2007
Last Verified: September 2005

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Syndrome
Apnea
Sleep Apnea Syndromes
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