The Natural History and Outcome of Sleep Disordered Breathing in Children

Overview

Sleep-disordered breathing in children is characterized by recurrent events of partial or complete upper airway obstruction during sleep, resulting in disruption of normal gas exchange (intermittent hypoxia and hypercapnia) and sleep fragmentation. The major symptom is snoring or noisy breathing. Sleep Disordered Breathing (SDB) is a wide spectrum of disorders that includes primary snoring, UARS and OSA. The main etiology for SDB in children is enlarged tonsils and adenoids and therefore the first line of treatment in pediatric SDB is adenotonsillectomy. The objectives of this study are: 1. To investigate the natural history of primary snoring 2. To investigate the effect of seasonality on SDB severity 3. To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in children 4. To characterize the children referred for repeated PSG following adenoidectomy or adenotonsillectomy and the indications for second PSG evaluation.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: September 2014

Arms, Groups and Cohorts

  • Winter Vs. Summer
    • All children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010
  • Primary snoring
    • All children that were diagosed with primary snoring at the Tel Aviv Medical center between 2005-2010
  • Adenotonsillectomy Vs. Adenoidectomy
    • All children that underwent adenotonsillectomy or tonsillectomy at the Tel Aviv Medical center between 2005-2008
  • repeated PSG
    • All children that underwent Adenoidectomy / Adenotonsillectomy and two PSG evaluations at the Tel Aviv Medical center between 2005-2012

Clinical Trial Outcome Measures

Primary Measures

  • Snoring
    • Time Frame: 4 years
    • Snoring will be assesd by PSQ-Pediatric sleep questionnaire
  • OSA severity (AHI, mean SpO2, SPo2 nadir)
    • Time Frame: 4 years
  • Daytime function
    • Time Frame: 4 years
    • Daytime function will be assesd by PSQ-Pediatric sleep questionnaire

Participating in This Clinical Trial

Inclusion Criteria

  • healthy normally developing children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010 Exclusion Criteria:

  • Chronic medical and neurodevelopmental conditions. – Congenital anomalies.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tel-Aviv Sourasky Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Riva Tauman, Dr., tauman@tlvmc.gov.il

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