Sleep Apnea
Conditions
Keywords
sleep apnea, phenotyping, cytochrome P450, drug metabolism, child
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 apnea syndrome (OSAS).
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 evaluate the activities of cytochrome P450 (CYP)1A2, N-acetyltransferase-2 (NAT-2), xanthine oxidase (XO)and CYP2D6 in children with OSAS and to determine the effect of OSAS treatment on the activities of these enzyme systems.
Interventions
DRUGDextromethorphan
0.5 mg/kg (maximum 30 mg)
DRUGCaffeine
Administered as 4 ounces of Coca-Cola
Sponsors
University of Louisville
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Children ages 4 to 16 years with suspected uncomplicated OSAS
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Caffeine urinary molar ratio | Pre and post T&A |
| Dextromethorphan urinary molar ratio | Pre and post T&A |
Countries
United States
Outcome results
None listed