The Natural History and Outcome of Sleep Disordered Breathing in Children

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 Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea; Sleep Disordered Breathing

• Study Type: Observational
• Enrollment (Anticipated): 2856

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Sourasky Medical Center
    • Principal Investigator: Riva Tauman, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 30 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy children 0-18 years old that underwent PSG evaluation at the Pediatric Sleep Center at Dana Children's hospital between 2005-2010

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: January 12, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 23, 2014
• Last Update Submitted That Met QC Criteria: January 21, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration
• Other Study ID Numbers: TASMC-14-RT-03-5510-CTIL