NCT05624372

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

May 22, 2018

Completed
4.5 years until next milestone

First Posted

Study publicly available on registry

November 22, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

May 21, 2024

Status Verified

May 1, 2024

Enrollment Period

6.9 years

First QC Date

May 21, 2018

Last Update Submit

May 20, 2024

Conditions

no Conditions

Outcome Measures

Primary Outcomes (1)

  • Speech perception in noise

    Hebrew Matrix

    1 day

Study Arms (2)

Investigator

Child and Adolescent Psychiatrists, Speech Therapists

Participant

Kids aged 4-18 diagnosed with ADHD

Diagnostic Test: hearing and cognitive assessment

Interventions

hearing and cognitive assessmentDIAGNOSTIC_TEST

psychiatric assessment, hearing assessment and brief cognitive assessment

Participant

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • Research group: Kids diagnosed with ADHD, without previous hearing problems.
  • Control group: Kids with regular development without previous hearing problems.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ADHD Medical Clinic, Child and Adolescent Psychiatry Unit, Sheba Medical Center

Ramat Gan, Israel

RECRUITING

MeSH Terms

Interventions

Hearing

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2018

First Posted

November 22, 2022

Study Start

May 22, 2018

Primary Completion

March 30, 2025

Study Completion

March 30, 2025

Last Updated

May 21, 2024

Record last verified: 2024-05

Locations

IL(1)