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Childhood Adenotonsillectomy Study for Children With OSAS (CHAT)

This study has been completed.
Sponsor:
Collaborators:
Harvard University
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00560859
First received: November 19, 2007
Last updated: November 10, 2015
Last verified: November 2015
Results First Received: July 13, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Conditions: Obstructive Sleep Apnea
Snoring
Interventions: Procedure: Adenotonsillectomy (AT) - removal of adenoids and tonsils
Other: Watchful Waiting

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Children were recruited at 7 academic sleep centers. Early in the trial the investigator at one center relocated and that center was withdrawn.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Early AT Surgery

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Watchful Waiting

Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.


Participant Flow:   Overall Study
    Early AT Surgery     Watchful Waiting  
STARTED     226     227  
COMPLETED     194     203  
NOT COMPLETED     32     24  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
These numbers represent all children randomized .

Reporting Groups
  Description
Early AT Surgery

Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.

Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome.

Watchful Waiting

Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.

Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period.

Total Total of all reporting groups

Baseline Measures
    Early AT Surgery     Watchful Waiting     Total  
Number of Participants  
[units: participants]
  226     227     453  
Age  
[units: Years]
Mean (Standard Deviation)
  6.6  (1.4)     6.5  (1.4)     6.6  (1.4)  
Age  
[units: participants]
     
<=18 years     226     227     453  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     125     109     234  
Male     101     118     219  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     1     2     3  
Asian     4     3     7  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     126     123     249  
White     74     81     155  
More than one race     15     12     27  
Unknown or Not Reported     6     6     12  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     16     21     37  
Not Hispanic or Latino     210     206     416  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     226     227     453  



  Outcome Measures
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1.  Primary:   Improvements in Attention/Executive Domain Index of the Developmental Neuropsychological Assessment (NEPSY) From Baseline to 7 Months.   [ Time Frame: The primary endpoint measure will occur at 7 months following the baseline visit. ]

2.  Secondary:   Change in Apnea Hypopnea Index (AHI) Score From Baseline to 7 Months   [ Time Frame: 7 months following the baseline visit. ]

3.  Secondary:   Change in Score of Pediatric Sleep Questionnaire Sleep-related Breathing Disorder Scale   [ Time Frame: 7 months following baseline. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Children under 5 years of age, in whom OSAS is common, were not included. Children on medications for ADHD or with prolonged oxygen-hemoglobin desaturation were also excluded, so results cannot be extrapolated to such children.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Susan S. Ellenberg
Organization: University of Pennsylvania
phone: 215-573-3904
e-mail: sellenbe@upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00560859     History of Changes
Other Study ID Numbers: 804695
5U01HL083129-05 ( US NIH Grant/Contract Award Number )
Study First Received: November 19, 2007
Results First Received: July 13, 2015
Last Updated: November 10, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board