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The Natural History and Outcome of Sleep Disordered Breathing in Children

The Natural History and Outcome of Sleep Disordered Breathing in Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02043353
Enrollment
2856
Registered
2014-01-23
Start date
2010-08-31
Completion date
Unknown
Last updated
2014-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Sleep Disordered Breathing

Brief 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.

Interventions

None listed

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Snoring4 yearsSnoring will be assesd by PSQ-Pediatric sleep questionnaire
OSA severity (AHI, mean SpO2, SPo2 nadir)4 years
Daytime function4 yearsDaytime function will be assesd by PSQ-Pediatric sleep questionnaire

Countries

Israel

Contacts

Primary ContactRiva Tauman, Dr.
tauman@tlvmc.gov.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026