Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Virginia Commonwealth University (VCU)

Status

Completed

Conditions

Sleep Apnea

Treatments

Drug: Caffeine

Drug: Dextromethorphan

Study type

Interventional

Funder types

Other

Identifiers

NCT00310323

OSAS 003-03

Details and patient eligibility

About

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).

Full 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.

Enrollment

69 patients

Sex

All

Ages

4 to 16 years old

Volunteers

No Healthy Volunteers

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