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Clinical Trials/NCT02043353
NCT02043353UnknownNot Applicable

The Natural History and Outcome of Sleep Disordered Breathing in Children

Tel-Aviv Sourasky Medical Center1 site in 1 country2,856 target enrollmentStarted: August 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
2,856
Locations
1
Primary Endpoint
Snoring

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
— to 30 Years (Child, Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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