The Natural History and Outcome of Sleep Disordered Breathing in Children

NCT ID: NCT02043353

Last Updated: 2014-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2856 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disordered Breathing Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Winter Vs. Summer

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

No interventions assigned to this group

Primary snoring

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

No interventions assigned to this group

Adenotonsillectomy Vs. Adenoidectomy

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

No interventions assigned to this group

repeated PSG

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

No interventions assigned to this group

Eligibility Criteria

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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.
Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Riva Tauman, Dr.

Role: CONTACT

Other Identifiers

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TASMC-14-RT-03-5510-CTIL

Identifier Type: -

Identifier Source: org_study_id

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