Back to resultsImpact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
Primary Purpose
Sleep Apnea Syndrome, Nonalcoholic Steatohepatitis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nCPAP
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndrome
Eligibility 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
Sites / Locations
- University Hospital AngersRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00152711
First Posted
September 8, 2005
Last Updated
February 12, 2007
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT00152711
Brief Title
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
Official Title
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis: A Prospective Cross Over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome, Nonalcoholic Steatohepatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
nCPAP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Frédéric Gagnadoux, MD
Phone
33(0)241353695
Email
frgagnadoux@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric Gagnadoux
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Gagnadoux, MD
Phone
33(0)241353695
Email
frgagnadoux@chu-angers.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
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