Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Primary Purpose
Child Neurocognitive Function
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
neuro trax system and a neurology test.
Sponsored by
About this trial
This is an interventional diagnostic trial for Child Neurocognitive Function
Eligibility Criteria
Inclusion Criteria:
- children between 6-18 years old.
- children with enlarged tonsils or adenoids.
- a sleep lab test before the procedure.
Exclusion Criteria:
- children under 6 years old and above 18 years old.
- patience that treated in ADHD / ADDOR with other neurocognitive disorder.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children With Enlargement Adenoid and Tonsils
Arm Description
Children With Enlargement Adenoid and Tonsils
Outcomes
Primary Outcome Measures
Neurocognitive Functions Among Children
neurology test using neuro trax system , to evaluate Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT04197518
First Posted
December 11, 2019
Last Updated
December 11, 2019
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04197518
Brief Title
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Official Title
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Neurocognitive Function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children With Enlargement Adenoid and Tonsils
Arm Type
Experimental
Arm Description
Children With Enlargement Adenoid and Tonsils
Intervention Type
Diagnostic Test
Intervention Name(s)
neuro trax system and a neurology test.
Intervention Description
the neurology will check the patience before and after tonsillectomy or adenotonsillectomy usung the neurotrax system, these parameters will be measured in this system : Non verbal memory, Go no go test, stroop interference, Visual spatial processing, Staged information processing speed, "catch" game, problem solving.
Primary Outcome Measure Information:
Title
Neurocognitive Functions Among Children
Description
neurology test using neuro trax system , to evaluate Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children between 6-18 years old.
children with enlarged tonsils or adenoids.
a sleep lab test before the procedure.
Exclusion Criteria:
children under 6 years old and above 18 years old.
patience that treated in ADHD / ADDOR with other neurocognitive disorder.
12. IPD Sharing Statement
Learn more about this trial
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
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