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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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Child Neurocognitive Function

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 11, 2019
    Last Updated
    December 11, 2019
    Sponsor
    Hillel Yaffe Medical Center
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    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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