Obstructive Sleep Apnea SyndromeNCT00456573
Cytokine Profiles in Children With Obstructive Sleep Apnea
A study testing tonsillectomy in people with Obstructive Sleep Apnea Syndrome, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea. Read more about this study
- Who is it for?
- Ages 18 months to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- tonsillectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2006to 1 Dec 2008
- 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 18 months to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- OSA documented by polysomnography and clinical symptoms.
- Patients with no symptoms of OSA and negative sleep questionnaire.
Who cannot join
- Significant systemic disease except mild asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls
The purpose of this study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.
Read the detailed description
We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. The mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. We will also recruit patients with no symptoms of OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the parents fill out a sleep questionnaire. We will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with OSA.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- tonsillectomy
- Keywords
- Pediatric Obstructive sleep apnea syndrome
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tonsillectomyProcedure or surgery
medically indicated tonsillectomy in subjects with and without OAS
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of cytokines released from PBMCs of OAS subjects and controls
Measured: just prior to surgery
Secondary outcomes (1)
cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study start1 Apr 2006
- Primary completion1 Sep 2008
- Study completion1 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuad M Baroody, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456573
- Sponsor's protocol ID
- 002 (14437B)
- Status last verified
- May 2023
- First submitted
- 3 Apr 2007
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local and Systemic Cytokine Profiles in Children With Obstructive Sleep Apnea and Controls
- ClinicalTrials.gov ID
- NCT00456573
- Acronym / sponsor ID
- 002 (14437B)
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Pediatric Obstructive sleep apnea syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Apr 2006 (actual)
- Primary completion
- 1 Sep 2008 (actual)
- Study completion
- 1 Dec 2008 (actual)
- First posted
- 5 Apr 2007 (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 study is to compare the cytokine profile of tonsillar and peripheral blood mononuclear cells in patients with obstructive sleep apnea (OSA) and to compare the blood mononuclear cell cytokine secretion profile between patients with obstructive sleep apnea and controls without apnea.
Detailed description
We will recruit subjects with OSA about to undergo adenotonsillectomy and collect a blood sample and portion of their tonsils after the induction of general anesthesia. The mononuclear cells will be isolated from both these tissues and stimulated with different markers and cytokines assayed and compared. We will also recruit patients with no symptoms of OSA undergoing unrelated elective surgery and ascertain the absence of OSA by having the parents fill out a sleep questionnaire. We will then collect blood samples from these patients after the induction of anesthesia and examine the cytokine secretion profile and compare it to that of the children with OSA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 months to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- OSA documented by polysomnography and clinical symptoms.
- Patients with no symptoms of OSA and negative sleep questionnaire.
Key exclusion criteria (1 listed)
- Significant systemic disease except mild asthma
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 |
|---|---|---|
| tonsillectomymedically indicated tonsillectomy in subjects with and without OAS | Procedure or surgery | – |
Primary outcome
levels of cytokines released from PBMCs of OAS subjects and controls
Time frame: just prior to surgery
1 secondary outcome
cytokine level comparison between PBMCs and tonsillar lymphocytes within OAS groups
Time frame: at time of surgery
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 6 May 2023.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Fuad M Baroody, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tonsillectomy in people with Obstructive Sleep Apnea Syndrome, run by University of Chicago at 1 site 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 2 inclusion and 1 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
levels of cytokines released from PBMCs of OAS subjects and controls (time frame: just prior to surgery). 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 6 May 2023.