The Natural History and Outcome of Sleep Disordered Breathing in Children

Obstructive Sleep Apnea Clinical Trial

Official title:

The Natural History and Outcome of Sleep Disordered Breathing in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02043353
• Other study ID #: TASMC-14-RT-03-5510-CTIL
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2014
• Last updated: January 21, 2014
• Start date: August 2010

Study information

• Verified date: January 2014
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Riva Tauman, Dr.
• Email: tauman[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2856
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Respiratory Aspiration
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Snoring	Snoring will be assesd by PSQ-Pediatric sleep questionnaire	4 years	No
Primary	OSA severity (AHI, mean SpO2, SPo2 nadir)		4 years	No
Primary	Daytime function	Daytime function will be assesd by PSQ-Pediatric sleep questionnaire	4 years	No