Sleep Apnea SyndromeNCT00152711
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
A study testing nCPAP in people with Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea Syndrome, Nonalcoholic Steatohepatitis
- What is being tested?
- nCPAP
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to not given
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychiatric disorder
- Other cause of liver disease
- Professional driver
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Angers
Angers
Frédéric Gagnadoux, MD, 33(0)241353695, frgagnadoux@chu-angers.fr
About this study
Official title: Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis: A Prospective Cross Over Trial
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.
- Conditions
- Sleep Apnea Syndrome, Nonalcoholic Steatohepatitis
- Being tested
- nCPAP
- Medical subject headings
- Sleep Apnea Syndromes, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nCPAPDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Frédéric Gagnadoux, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152711
- Sponsor's protocol ID
- PHRC 03-07
- Status last verified
- Sep 2005
- First submitted
- 8 Sep 2005
- Last updated
- 13 Feb 2007
- Results posted
- No