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CompletedNCT00310323Updated Mar 19, 2009

Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

An interventional study of Dextromethorphan and Caffeine in Sleep Apnea, sponsored by Virginia Commonwealth University. Completed at 2 sites in United States. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2009-03-19.

Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Non-randomized
Ages
4 Years to 16 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Sleep Apnea

Keywords

  • sleep apnea
  • phenotyping
  • cytochrome P450
  • drug metabolism
  • child
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 69 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.

Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children ages 4 to 16 years with suspected uncomplicated OSAS

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    1

    Children with OSAS identified via sleep study

    Drug: Dextromethorphan · Drug: Caffeine

Interventions

  • DrugDextromethorphan

    0.5 mg/kg (maximum 30 mg)

  • DrugCaffeine

    Administered as 4 ounces of Coca-Cola

06

What researchers measure

Primary outcomes

  1. Caffeine urinary molar ratio

    Time frame: Pre and post T&A

  2. Dextromethorphan urinary molar ratio

    Time frame: Pre and post T&A

07

Study locations

2 sites
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00310323
Lead sponsor
Virginia Commonwealth University
Collaborators
University of Louisville
First posted
Apr 3, 2006
Start date
Jan 2003
Primary completion
Feb 2006
Completion
Feb 2006
Last update
Mar 19, 2009

Study contacts

Mary Jayne Kennedy, Pharm.D.
principal investigator · Virginia Commonwealth University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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