Inflammatory Markers in Infants With Obstructive Sleep Apnea

NCT01058590 | Unknown

• 1 other identifier: SOR494810ctil
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

Inflammation; Adenotonsillectomy

Outcome Measures

Primary Outcomes (1)

• Analysis of average change in inflammatory markers, before -to-after T%A.

  February 2011

Eligibility Criteria

• Age: 1 Month - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka UMC

Beersheba, 84101, Israel

Location

Related Publications (1)

• 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.

  PMID: 19009600 BACKGROUND

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).

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Inflammation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aviv D Goldbart, MD

  Soroka UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aviv D Goldbart, MD

CONTACT

97286244465; avivgold@bgu.ac.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2010
• First Posted: January 28, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2012
• Last Updated: January 28, 2010

Record last verified: 2010-01

Locations

IL (1)