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Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Primary Purpose

Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dextromethorphan
Caffeine
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea focused on measuring sleep apnea, phenotyping, cytochrome P450, drug metabolism, child

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • University of Louisville
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Children with OSAS identified via sleep study

Outcomes

Primary Outcome Measures

Caffeine urinary molar ratio
Dextromethorphan urinary molar ratio

Secondary Outcome Measures

Full Information

First Posted
March 30, 2006
Last Updated
March 17, 2009
Sponsor
Virginia Commonwealth University
Collaborators
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT00310323
Brief Title
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
Official Title
Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Virginia Commonwealth University
Collaborators
University of Louisville

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
Keywords
sleep apnea, phenotyping, cytochrome P450, drug metabolism, child

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Children with OSAS identified via sleep study
Intervention Type
Drug
Intervention Name(s)
Dextromethorphan
Intervention Description
0.5 mg/kg (maximum 30 mg)
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Administered as 4 ounces of Coca-Cola
Primary Outcome Measure Information:
Title
Caffeine urinary molar ratio
Time Frame
Pre and post T&A
Title
Dextromethorphan urinary molar ratio
Time Frame
Pre and post T&A

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Jayne Kennedy, Pharm.D.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

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