- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04197518
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
December 11, 2019 updated by: Hillel Yaffe Medical Center
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 14 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Children With Enlargement Adenoid and Tonsils
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neurocognitive Functions Among Children
Time Frame: 2 years
|
neurology test using neuro trax system , to evaluate Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2020
Primary Completion (Anticipated)
January 1, 2021
Study Completion (Anticipated)
January 1, 2022
Study Registration Dates
First Submitted
December 11, 2019
First Submitted That Met QC Criteria
December 11, 2019
First Posted (Actual)
December 13, 2019
Study Record Updates
Last Update Posted (Actual)
December 13, 2019
Last Update Submitted That Met QC Criteria
December 11, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0042-18-HYMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.