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Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

This study has been completed.
University of Louisville
Information provided by:
Virginia Commonwealth University Identifier:
First received: March 30, 2006
Last updated: March 17, 2009
Last verified: March 2009
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 Intervention
Sleep Apnea
Drug: Dextromethorphan
Drug: Caffeine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

Resource links provided by NLM:

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Caffeine urinary molar ratio [ Time Frame: Pre and post T&A ]
  • Dextromethorphan urinary molar ratio [ Time Frame: Pre and post T&A ]

Enrollment: 69
Study Start Date: January 2003
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00310323

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
University of Louisville
Principal Investigator: Mary Jayne Kennedy, Pharm.D. Virginia Commonwealth University
  More Information

Responsible Party: Mary Jayne Kennedy, Pharm.D., Virginia Commonwealth University Identifier: NCT00310323     History of Changes
Other Study ID Numbers: OSAS 003-03
Study First Received: March 30, 2006
Last Updated: March 17, 2009

Keywords provided by Virginia Commonwealth University:
sleep apnea
cytochrome P450
drug metabolism

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents processed this record on April 28, 2017