Obstructive Sleep Apnea SyndromeNCT01058590
Inflammatory Markers in Infants With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea Syndrome, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in turn, is associated with significant behavioral, learning, and heart problems. Adenotonsillectomy (T\&A, meaning the removal of tonsils and adenoids) is the most common treatment for the problem .Diagnosis of OSAS in children is… Read more about this study
- Who is it for?
- Ages 1 month to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2010to Feb 2012
- Phase
- Observational
- 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 1 month to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 0-3 years diagnosed with obstructive sleep apnea syndrome, refferred to removal of tonsills and adenoids
Who may be able to join
- Children aged 1 month-3 years
- Diagnosis of obstructive sleep apnea syndrome(according to a sleep study)
Who cannot join
- Congenital disorders of the respiratory system
- Congenital craniofacial disorders (retrognathia, Trisomy 21)
- Use of anti inflammatory medications (like: montelukast, budesonide) up to 4 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in turn, is associated with significant behavioral, learning, and heart problems. Adenotonsillectomy (T\&A, meaning the removal of tonsils and adenoids) is the most common treatment for the problem .Diagnosis of OSAS in children is based on overnight polysomnography (sleep study). Recent studies suggest that upper airway and systemic inflammatory changes exists in school-age children and adults with OSAS, and that anti inflammatory therapy can improve respiratory parameters during sleep and reduce adenoid size, similar to surgery. However, there are no data in the literature on inflammatory changes in infants with the disorder.
Healthcare resources utilization, a sensitive marker for diseases is consumed by young children (<3y) with OSAS more then healthy children, from their first year of life We hypothesize that infants and young children with OSAS present local inflammatory changes of the airways as well as systemic inflammation (in the blood or urine) that contribute to the learning, growing and heart associated medical problems. The Aims of the present study are to characterize the local and systemic inflammatory changes of young children with OSAS, and to evaluate their associated medical problems at diagnosis and after therapy (T\&A) If indeed inflammation is "responsible" for the development of OSAS at such a young age it should be reduced following therapy (i.e. T\&A). In such a case bio-markers may become a part of the algorithms for diagnosis and follow up of such patients.
Read the detailed description
Specific Aims:
- To conduct a trial evaluating the effect of Adenonsillectomy in infants (1-36 months of age), with OSA. Outcome measures will include polysomnographic findings conducted prior to and 12 weeks following surgery.
- To identify the presence of inflammatory markers (such as, but not only Leukotriene B4, Leukotriene C4/D4/E4, Isoprostane-8, IL-6, TNF-alpha, and other pro inflammatory cytokines) in the peripheral blood (prior and after therapy), and urine (Leukotriene E-4, and others) and correlate their local and systemic expression prior and after therapy to the magnitude of therapy-associated response.
Study Duration: Two years (initial recruitment will be completed within the initial 12 months of the study). Assessment of the samples obtained throughout the study will be done at the latter part of the study.
Setting: Soroka University Hospital . The Sleep Laboratory in Soroka UMC, is the only pediatric one in the city of Beer Sheva and surroundings, evaluates over 1,000 children/year for a variety of sleep disorders, among which >700 are referred for suspected OSAS, among them 100 infants< 2 years/ year.
All children referred for surgery are admitted in the Dept. of Pediatrics where the PI works. We intend to approach all the children prior to surgery and offer them to participate in this study. Those who are interested will gain a sleep study following surgery to validate (or to rull out) the presence of residual OSA and if there is a need, to continue follow up in the pediatric sleep outpatient clinic in Soroka UMC.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Inflammation, Adenotonsillectomy
- Medical subject headings
- Sleep Apnea, Obstructive, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of average change in inflammatory markers, before -to-after T%A.
Measured: February 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Aviv D Goldbart, MD, Principal investigator, Soroka UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058590
- Sponsor's protocol ID
- SOR494810ctil
- Status last verified
- Jan 2010
- First submitted
- 27 Jan 2010
- Last updated
- 28 Jan 2010
- Results posted
- No
Publications
Goldbart AD, Tal A. Inflammation and sleep disordered breathing in children: a state-of-the-art review. Pediatr Pulmonol. 2008 Dec;43(12):1151-60. doi: 10.1002/ppul.20943.
PubMed 19009600
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Markers in Infants With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01058590
- Acronym / sponsor ID
- SOR494810ctil
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Inflammation, Adenotonsillectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 28 Jan 2010 (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.
Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in turn, is associated with significant behavioral, learning, and heart problems. Adenotonsillectomy (T\&A, meaning the removal of tonsils and adenoids) is the most common treatment for the problem .Diagnosis of OSAS in children is based on overnight polysomnography (sleep study). Recent studies suggest that upper airway and systemic inflammatory changes exists in school-age children and adults with OSAS, and that anti inflammatory therapy can improve respiratory parameters during sleep and reduce adenoid size, similar to surgery. However, there are no data in the literature on inflammatory changes in infants with the disorder.
Healthcare resources utilization, a sensitive marker for diseases is consumed by young children (<3y) with OSAS more then healthy children, from their first year of life We hypothesize that infants and young children with OSAS present local inflammatory changes of the airways as well as systemic inflammation (in the blood or urine) that contribute to the learning, growing and heart associated medical problems. The Aims of the present study are to characterize the local and systemic inflammatory changes of young children with OSAS, and to evaluate their associated medical problems at diagnosis and after therapy (T\&A) If indeed inflammation is "responsible" for the development of OSAS at such a young age it should be reduced following therapy (i.e. T\&A). In such a case bio-markers may become a part of the algorithms for diagnosis and follow up of such patients.
Detailed description
Specific Aims:
- To conduct a trial evaluating the effect of Adenonsillectomy in infants (1-36 months of age), with OSA. Outcome measures will include polysomnographic findings conducted prior to and 12 weeks following surgery.
- To identify the presence of inflammatory markers (such as, but not only Leukotriene B4, Leukotriene C4/D4/E4, Isoprostane-8, IL-6, TNF-alpha, and other pro inflammatory cytokines) in the peripheral blood (prior and after therapy), and urine (Leukotriene E-4, and others) and correlate their local and systemic expression prior and after therapy to the magnitude of therapy-associated response.
Study Duration: Two years (initial recruitment will be completed within the initial 12 months of the study). Assessment of the samples obtained throughout the study will be done at the latter part of the study.
Setting: Soroka University Hospital . The Sleep Laboratory in Soroka UMC, is the only pediatric one in the city of Beer Sheva and surroundings, evaluates over 1,000 children/year for a variety of sleep disorders, among which >700 are referred for suspected OSAS, among them 100 infants< 2 years/ year.
All children referred for surgery are admitted in the Dept. of Pediatrics where the PI works. We intend to approach all the children prior to surgery and offer them to participate in this study. Those who are interested will gain a sleep study following surgery to validate (or to rull out) the presence of residual OSA and if there is a need, to continue follow up in the pediatric sleep outpatient clinic in Soroka UMC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 0-3 years diagnosed with obstructive sleep apnea syndrome, refferred to removal of tonsills and adenoids
Key inclusion criteria (2 listed)
- Children aged 1 month-3 years
- Diagnosis of obstructive sleep apnea syndrome(according to a sleep study)
Key exclusion criteria (3 listed)
- Congenital disorders of the respiratory system
- Congenital craniofacial disorders (retrognathia, Trisomy 21)
- Use of anti inflammatory medications (like: montelukast, budesonide) up to 4 weeks prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Analysis of average change in inflammatory markers, before -to-after T%A.
Time frame: February 2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2010.
- Background: PubMed 19009600Goldbart AD, Tal A. Inflammation and sleep disordered breathing in children: a state-of-the-art review. Pediatr Pulmonol. 2008 Dec;43(12):1151-60. doi: 10.1002/ppul.20943.
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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.
Aviv D Goldbart, MD principal investigator
Soroka UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome, run by Soroka University Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Jan 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aviv D Goldbart, MD (97286244465, avivgold@bgu.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of average change in inflammatory markers, before -to-after T%A. (time frame: February 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01058590, which also lists 1 linked publication.
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 28 Jan 2010.