no ConditionsMENCT05624372
Speech Perception in Noise in Children With ADHD
An observational study of no Conditions, run by Sheba Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- no Conditions
- What is being tested?
- hearing and cognitive assessment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 22 May 2018to 30 Mar 2025
- Phase
- Observational
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- Research group: Kids diagnosed with ADHD, without previous hearing problems.
- Control group: Kids with regular development without previous hearing problems.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
Ramat Gan
Prof. Doron Gothelf, MD, 972-52-6669360, gothelf@post.tau.ac.il
Maya Elazar, MD
About this study
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.
Read the 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)
- Conditions
- no Conditions
- Being tested
- hearing and cognitive assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hearing and cognitive assessmentDiagnostic test
psychiatric assessment, hearing assessment and brief cognitive assessment
| Study group | Role | What they receive |
|---|---|---|
| Investigator | Child and Adolescent Psychiatrists, Speech Therapists | |
| Participant | Kids aged 4-18 diagnosed with ADHD Receives: Diagnostic Test: hearing and cognitive assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech perception in noise
Hebrew Matrix
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start22 May 2018
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no ConditionsStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Maya Elazar, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624372
- Sponsor's protocol ID
- SHEBA-17-3855-ME-CTIL
- Acronym
- ME
- Status last verified
- May 2024
- First submitted
- 21 May 2018
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Perception in Noise in Children With ADHD
- ClinicalTrials.gov ID
- NCT05624372
- Acronym / sponsor ID
- ME / SHEBA-17-3855-ME-CTIL
- Conditions
- no Conditions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- 22 May 2018 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 22 Nov 2022 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigator | – | –Child and Adolescent Psychiatrists, Speech Therapists |
| Participant | – | Diagnostic Test: hearing and cognitive assessmentKids aged 4-18 diagnosed with ADHD |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (2 listed)
- Research group: Kids diagnosed with ADHD, without previous hearing problems.
- Control group: Kids with regular development without previous hearing problems.
Key exclusion criteria (6 listed)
- Having previous hearing problems or disorders
- Other psychiatric disorders
- Treatment with psychiatric medications other than stimulants
- Having autism
- Having severe learning disabilities.
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 |
|---|---|---|
| hearing and cognitive assessmentpsychiatric assessment, hearing assessment and brief cognitive assessment | Diagnostic test | Participant |
Primary outcome
Speech perception in noise
Time frame: 1 day
Hebrew Matrix
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center
Ramat Gan, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of no Conditions, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 6 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 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech perception in noise (time frame: 1 day). 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 21 May 2024.