Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Completed

CT.gov ID

NCT00310323

Collaborator

University of Louisville (Other)

Enrollment

Locations

Arm

Duration (Months)

34.5

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Drug: Dextromethorphan Drug: Caffeine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

69 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Feb 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Children with OSAS identified via sleep study	Drug: Dextromethorphan 0.5 mg/kg (maximum 30 mg) Drug: Caffeine Administered as 4 ounces of Coca-Cola

Arm

Intervention/Treatment

Experimental: 1

Children with OSAS identified via sleep study

Drug: Dextromethorphan

0.5 mg/kg (maximum 30 mg)

Drug: Caffeine

Administered as 4 ounces of Coca-Cola

Outcome Measures

Primary Outcome Measures

Caffeine urinary molar ratio [Pre and post T&A]
Dextromethorphan urinary molar ratio [Pre and post T&A]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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