NCT04041440

Brief Summary

clEAR's auditory brain training has been shown to be effective in improving childrens' abilities to recognize the speech of generic talkers in a laboratory setting. In the proposed research, the researchers will build upon these results and assess the extent to which auditory brain training delivered via the web enhances children's abilities to recognize the speech of a potential classroom teacher and diminishes their communication challenges that are associated with significant hearing loss. First, investigators will conduct focus groups with children who have undergone training with the research version of clEAR's pediatric games, then they will recode the games from LabView to Java Script, making changes in the games in response to the focus group comments, and finally, they will collect data from 20 children to assess whether web-based auditory brain training improves their abilities to recognize the speech of their (hypothetical) upcoming school year's classroom teacher.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

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

July 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 10, 2021

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

July 26, 2019

Results QC Date

April 12, 2021

Last Update Submit

October 12, 2021

Conditions

Keywords

Auditory trainingChildren with hearing loss

Outcome Measures

Primary Outcomes (1)

  • Percentage of Words Identified Before and After Training

    The measure is percent of 50 common words correctly identified. Words were presented through the application and responses were recorded and scored by the audiologist administering the test.

    Before and after the four week training period

Secondary Outcomes (3)

  • Processing Speed

    over course of 4 weeks

  • Working Memory

    over course of 4 weeks

  • Subjective Assessment of clEAR Games on a 7-Point Scale

    Measured once, after the four week training period

Study Arms (1)

Auditory Training

EXPERIMENTAL

Pre- and post assessments of auditory training intervention

Behavioral: clEAR auditory training

Interventions

Children play auditory brain training computer games

Auditory Training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children with moderate to severe hearing loss.

You may not qualify if:

  • Must be native English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 62220, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chief Operating Officer
Organization
Customized Learning Exercises for Aural Rehabilitation

Study Officials

  • Chris A Cardinal, PhD

    clEAR: Customized Hearing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within subjects A1 - A2 - B1 - B2 design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2019

First Posted

August 1, 2019

Study Start

September 1, 2019

Primary Completion

September 16, 2020

Study Completion

September 16, 2020

Last Updated

November 10, 2021

Results First Posted

November 10, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Only descriptive data will be shared with other researchers

Locations