The Natural History and Outcome of Sleep Disordered Breathing in Children

Tel Aviv Sourasky Medical Center

Status: Unknown

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Study type: Observational

Funder types: Other

Identifiers

NCT02043353

TASMC-14-RT-03-5510-CTIL

Details and patient eligibility

About

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.

Enrollment: 2,856 estimated patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,856 participants in 4 patient groups

Winter Vs. Summer

Description:

All children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010

Primary snoring

Description:

All children that were diagosed with primary snoring at the Tel Aviv Medical center between 2005-2010

Adenotonsillectomy Vs. Adenoidectomy

Description:

All children that underwent adenotonsillectomy or tonsillectomy at the Tel Aviv Medical center between 2005-2008

repeated PSG

Description:

All children that underwent Adenoidectomy / Adenotonsillectomy and two PSG evaluations at the Tel Aviv Medical center between 2005-2012