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Completed

NCT Number: NCT00310323

Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea

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).

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

4 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dextromethorphan

Drug

0.5 mg/kg (maximum 30 mg)

Caffeine

Drug

Administered as 4 ounces of Coca-Cola

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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • University of Louisville

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Apr 3, 2006
Registry last updated
Mar 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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