Inflammatory Markers in Infants 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: NCT01058590
Recruitment Status : Unknown
Verified January 2010 by Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2010
Last Update Posted : January 28, 2010
Information provided by:
Soroka University Medical Center

Brief 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 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.

Condition or disease
Obstructive Sleep Apnea Syndrome

Detailed Description:

Specific Aims:

  1. 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.
  2. 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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Markers in Infants With Obstructive Sleep Apnea
Study Start Date : February 2010
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Primary Outcome Measures :
  1. Analysis of average change in inflammatory markers, before -to-after T%A. [ Time Frame: February 2011 ]

Biospecimen Retention:   Samples Without DNA
Serum and urine will be obtained before therapy (T%A) snd 3 months afterwards. The serum will be stored at -70 throughout the study in the PI's Lab (DR.Goldbart) At the end of the study the sampled will be assessed for the presence of inflammatory markers (cytokines).

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children aged 0-3 years diagnosed with obstructive sleep apnea syndrome, refferred to removal of tonsills and adenoids

Inclusion Criteria:

  • Children aged 1 month-3 years
  • Diagnosis of obstructive sleep apnea syndrome(according to a sleep study)

Exclusion Criteria:

  • 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.

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): NCT01058590

Contact: Aviv D Goldbart, MD 97286244465

Soroka UMC Not yet recruiting
Beer Sheva, Israel, 84101
Contact: Aviv Goldbart    97286244465      
Sponsors and Collaborators
Soroka University Medical Center
Principal Investigator: Aviv D Goldbart, MD Soroka UMC

Responsible Party: Aviv Goldbart MD, Soroka UMC Identifier: NCT01058590     History of Changes
Other Study ID Numbers: SOR494810ctil
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: January 28, 2010
Last Verified: January 2010

Keywords provided by Soroka University Medical Center:

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