Status:
COMPLETED
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
University of Louisville
Conditions:
Sleep Apnea
Eligibility:
All Genders
4-16 years
Phase:
NA
Brief Summary
The purpose of this research study is to determine the effect of chronic nighttime low oxygen saturations on selected body systems (liver) that break down drugs in children with obstructive sleep apne...
Detailed Description
The purpose of this study is to determine the effect of chronic intermittent nocturnal hypoxia on selected hepatic drug-metabolizing enzyme systems in children with OSAS. The specific aims are to eval...
Eligibility Criteria
Inclusion
- Children ages 4 to 16 years with suspected uncomplicated OSAS
Exclusion
- Children with complicated OSAS (craniofacial abnormalities, neuromuscular disorders)
- Children who are receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity
- Children who are exposed to second hand smoke for greater than 8 hours per day.
- Children with hypersensitivity to caffeine or dextromethorphan
- Children who are receiving corticosteroids or thyroid hormone
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00310323
Start Date
January 1 2003
End Date
February 1 2006
Last Update
March 19 2009
Active Locations (2)
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1
University of Louisville
Louisville, Kentucky, United States, 40202
2
Virginia Commonwealth University
Richmond, Virginia, United States, 23298