The Natural History and Outcome of Sleep Disordered Breathing in Children

NCT02043353 | Unknown

• 1 other identifier: TASMC-14-RT-03-5510-CTIL
• Study Type: observational
• Target: 2,856
• Locations: 1 country
• Sites: 1

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. 1.To investigate the natural history of primary snoring
2. 2.To investigate the effect of seasonality on SDB severity
3. 3.To compare the effect of adenoidectomy to adenotonsillectomy in the treatment of SDB in children
4. 4.To characterize the children referred for repeated PSG following adenoidectomy or adenotonsillectomy and the indications for second PSG evaluation.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• healthy normally developing children that underwent PSG evaluation at the Tel Aviv Medical center between 2005-2010

You may not qualify if:

• Chronic medical and neurodevelopmental conditions.
• Congenital anomalies.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Riva Tauman, Dr.

CONTACT

tauman@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2014
• First Posted: January 23, 2014
• Study Start: August 1, 2010
• Primary Completion: September 1, 2014
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

IL (1)