Speech Perception in Noise in Children With ADHD | NCT05624372

Studies
Speech Perception in Noise in Children With ADHD

NCT05624372

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

May 21, 2024Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

no Conditions

Interventions

hearing and cognitive assessment

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 22, 2018Actual

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

Mar 30, 2025Estimated

First Submitted Date

May 21, 2018

First Submission Date that Met QC Criteria

Nov 21, 2022

First Posted Date

Nov 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2024

Last Update Posted Date

May 21, 2024Actual

Name	Class
Tel Aviv University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigator		Child and Adolescent Psychiatrists, Speech Therapists
Participant		Kids aged 4-18 diagnosed with ADHD	Diagnostic Test: hearing and cognitive assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hearing and cognitive assessment	Diagnostic Test	psychiatric assessment, hearing assessment and brief cognitive assessment	Participant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Speech perception in noise	Hebrew Matrix	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center	Recruiting	Ramat Gan			Israel

Intervention Browse Module

MeSH Terms

ID	Term
D006309	Hearing

Ancestor Terms

ID	Term
D000084323	Vestibulocochlear Physiological Phenomena
D010829	Physiological Phenomena
D012677	Sensation
D009424	Nervous System Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided