Improving Perception of Speech in Noise in Children With Communication Disorders (L2F)

August 27, 2021 updated by: Smarty Ears
Smarty Ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target to be heard). The study will attempt to validate the technology and gather initial design feedback from clinicians and caregivers and from children with ASD and HL.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recent evidence indicates that listening in interrupted noise can provide perceptual benefits, such as remapping the auditory environment and learning to use acoustic cues. The developed technology, uses adaptive listening training that automatically increases noise level difficulty as performance improves, and includes age appropriate rewards to maintain interest. The mobile app includes an initial and final screening, a training system that administers training via the child's own mobile device, and detailed performance dashboard. The study will attempt to validate the technology by gathering feedback from clinicians and caregivers and from children with ASD and HL.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06515
        • Southern Connecticut State University
    • Virginia
      • Hampton, Virginia, United States, 23669
        • Hampton University

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

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • For all children: normal or corrected to normal vision.
  • For children with typical development normal or corrected to normal vision + normal hearing.
  • For children with HL Children must have at least one year experience with amplification (i.e Hearing aids) and no threshold> 70 dB.

Exclusion Criteria:

  • To participate, all children must be able to comply with directions and engage in tasks that require some expressive language response on the language and cognitive measures (i.e. children who are considered to be in the "word combinations" or "sentences expressive language" phase; Tager-Flusberg et al., 2009).

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with an autism spectrum disorder
The intervention as described above with children with an ASD.
Other: Audiovisual speech training in noise for children
Children will participate in listening training in the form of an iPad app
Experimental: Children with Hearing Loss
Other: Audiovisual speech training in noise for children
Children will participate in listening training in the form of an iPad app
Experimental: Typically developing children with normal hearing acuity
Other: Audiovisual speech training in noise for children
Children will participate in listening training in the form of an iPad app

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily training performance
Time Frame: 5 days a week for 4 weeks (30 minutes/day)
Daily performance level based on words correct as a function of SNR and the average SNR over the course of training for 4 weeks
5 days a week for 4 weeks (30 minutes/day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Smarty Ears

Collaborators

National Institutes of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Haskins Laboratories
Southern Connecticut State University

Investigators

  • Principal Investigator: Barbara Fernandes, M.S, Smarty Ears

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 3, 2020

Primary Completion (Actual)

May 31, 2021

Study Completion (Actual)

May 31, 2021

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 16, 2020

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Listening2Faces
  • 3R43DC017405-01A1S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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