Child Neurocognitive FunctionNCT04197518
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
A study testing neuro trax system and a neurology test. in people with Child Neurocognitive Function, run by Hillel Yaffe Medical Center.
Trial summary
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Child Neurocognitive Function
- What is being tested?
- neuro trax system and a neurology test.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children between 6-18 years old.
- children with enlarged tonsils or adenoids.
- a sleep lab test before the procedure.
Who cannot join
- children under 6 years old and above 18 years old.
- patience that treated in ADHD / ADDOR with other neurocognitive disorder.
About this study
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
- Conditions
- Child Neurocognitive Function
- Being tested
- neuro trax system and a neurology test.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuro trax system and a neurology test.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Children With Enlargement Adenoid and Tonsils | Experimental | Children With Enlargement Adenoid and Tonsils Receives: Diagnostic Test: neuro trax system and a neurology test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jan 2020 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Neurocognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197518
- Sponsor's protocol ID
- 0042-18-HYMC
- Status last verified
- Dec 2019
- First submitted
- 11 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT04197518
- Acronym / sponsor ID
- 0042-18-HYMC
- Conditions
- Child Neurocognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Enlargement Adenoid and Tonsils | Experimental | Diagnostic Test: neuro trax system and a neurology test.Children With Enlargement Adenoid and Tonsils |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- children between 6-18 years old.
- children with enlarged tonsils or adenoids.
- a sleep lab test before the procedure.
Key exclusion criteria (2 listed)
- children under 6 years old and above 18 years old.
- patience that treated in ADHD / ADDOR with other neurocognitive disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuro trax system and a neurology test.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. | Diagnostic test | Children With Enlargement Adenoid and Tonsils |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing neuro trax system and a neurology test. in people with Child Neurocognitive Function, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive Functions Among Children (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.