- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624372
Speech Perception in Noise in Children With ADHD (ME)
May 20, 2024 updated by: Dr. Maya Elazar, Sheba Medical Center
We are going to assess an ability of speech perception in voice in children diagnosed with ADHD (Attention Deficit Hyperactivity Disorder), comparing to normal control group.
This is an attempt to understand the factors influencing on this ability.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Participants will undergo a battery of hearing tests -Standard Hearing Test; Speech Perception in Noise - Hebrew Matrix; Transient Evoked Otoacoustic Emission (TEOAE) and cognitive tests - Working Memory Test (from (Wechsler Intelligence Scale for Children, WISC); Visual Attention Test (TMT (Trail Making Test)); Non-Verbal Intelligence Test (RAVEN)
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ramat-Gan, Israel
- Recruiting
- ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
-
Contact:
- Prof. Doron Gothelf, MD
- Phone Number: 972-52-6669360
- Email: gothelf@post.tau.ac.il
-
Principal Investigator:
- Maya Elazar, MD
-
-
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
6 months to 14 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Kids aged 4-18, diagnosed with ADHD, who get treatment and follow-ups in the ADHD outpatient clinic in the Sheba Medical Center
Description
Inclusion Criteria:
- Research group: Kids diagnosed with ADHD, without previous hearing problems.
- Control group: Kids with regular development without previous hearing problems.
Exclusion Criteria:
For both groups:
- Having previous hearing problems or disorders
- Other psychiatric disorders
- Treatment with psychiatric medications other than stimulants
- Having autism
- Having severe learning disabilities.
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Investigator
Child and Adolescent Psychiatrists, Speech Therapists
|
|
|
Participant
Kids aged 4-18 diagnosed with ADHD
|
psychiatric assessment, hearing assessment and brief cognitive assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech perception in noise
Time Frame: 1 day
|
Hebrew Matrix
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 (Actual)
May 22, 2018
Primary Completion (Estimated)
March 30, 2025
Study Completion (Estimated)
March 30, 2025
Study Registration Dates
First Submitted
May 21, 2018
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
November 22, 2022
Study Record Updates
Last Update Posted (Actual)
May 21, 2024
Last Update Submitted That Met QC Criteria
May 20, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-17-3855-ME-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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