Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea
• Interventions: Drug: Dextromethorphan; Drug: Caffeine

• Registration Number: NCT00310323
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2006-03-30
• Study First Submitted QC: 2006-03-30
• Study First Posted: 2006-04-03
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-17
• Last Update Posted: 2009-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Dextromethorphan	Children with OSAS identified via sleep study
1	Caffeine	Children with OSAS identified via sleep study

Primary Outcome Measures

Name	Time	Method
Dextromethorphan urinary molar ratio	Pre and post T&A
Caffeine urinary molar ratio	Pre and post T&A

Trial Locations

Locations (2)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States