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NCT00152711 Clinical Trial

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

Nonalcoholic Steatohepatitis Clinical Trial

Official title:
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis: A Prospective Cross Over Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00152711
Other study ID # PHRC 03-07
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2005
Last updated February 12, 2007
Start date September 2004

Study information
Verified date September 2005
Source University Hospital, Angers
Contact Frédéric Gagnadoux, MD
Phone 33(0)241353695
Email frgagnadoux@chu-angers.fr
Is FDA regulated No
Health authority France: French General Health Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• nCPAP

Locations
Country Name City State
France University Hospital Angers Angers

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

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