Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310323
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : March 19, 2009
University of Louisville
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Sleep Apnea Drug: Dextromethorphan Drug: Caffeine Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : January 2003
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

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

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Mary Jayne Kennedy, Pharm.D., Virginia Commonwealth University Identifier: NCT00310323     History of Changes
Other Study ID Numbers: OSAS 003-03
First Posted: April 3, 2006    Key Record Dates
Last Update Posted: March 19, 2009
Last Verified: March 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