Sleep ApneaNCT00310323
Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
A study testing Dextromethorphan and Caffeine in people with Sleep Apnea, run by Virginia Commonwealth University at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Dextromethorphan and Caffeine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2003to Feb 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 4 to 16 years with suspected uncomplicated OSAS
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Louisville
Louisville, Kentucky, 40202
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Effect of Chronic Intermittent Nocturnal Hypoxia on 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).
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.
- Conditions
- Sleep Apnea
- Being tested
- Dextromethorphan, Caffeine
- Keywords
- sleep apnea, phenotyping, cytochrome P450, drug metabolism, child
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextromethorphanDrug
0.5 mg/kg (maximum 30 mg)
CaffeineDrug
Administered as 4 ounces of Coca-Cola
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Children with OSAS identified via sleep study Receives: Drug: Dextromethorphan; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caffeine urinary molar ratio
Measured: Pre and post T&A
Dextromethorphan urinary molar ratio
Measured: Pre and post T&A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startJan 2003
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville
- Investigators
- Mary Jayne Kennedy, Pharm.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310323
- Sponsor's protocol ID
- OSAS 003-03
- Status last verified
- Mar 2009
- First submitted
- 30 Mar 2006
- Last updated
- 19 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Intermittent Nocturnal Hypoxia on Hepatic Drug Biotransformation in Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00310323
- Acronym / sponsor ID
- OSAS 003-03
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, phenotyping, cytochrome P450, drug metabolism, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- University of Louisville
- Study start
- Jan 2003
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 3 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Dextromethorphan, Drug: CaffeineChildren with OSAS identified via sleep study |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children ages 4 to 16 years with suspected uncomplicated OSAS
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextromethorphan0.5 mg/kg (maximum 30 mg) | Drug | 1 |
| CaffeineAdministered as 4 ounces of Coca-Cola | Drug | 1 |
Primary outcome
Caffeine urinary molar ratio
Time frame: Pre and post T&A
Dextromethorphan urinary molar ratio
Time frame: Pre and post T&A
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Jayne Kennedy, Pharm.D. principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextromethorphan and Caffeine in people with Sleep Apnea, run by Virginia Commonwealth University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caffeine urinary molar ratio (time frame: Pre and post T&A). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2009.