Improving Perception of Speech in Noise in Children With Communication Disorders

NCT ID: NCT04473729

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2021-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Speech Perception

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The model is ABA design, that is participants get an initial, pre-treatment noise assessment, then get individualized training, then get a post-noise assessment. This is designed to look for change from baseline after training.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Children with an autism spectrum disorder

The intervention as described above with children with an ASD.

Group Type EXPERIMENTAL

Audiovisual speech training in noise for children

Intervention Type OTHER

Children will participate in listening training in the form of an iPad app

Children with Hearing Loss

Group Type EXPERIMENTAL

Audiovisual speech training in noise for children

Intervention Type OTHER

Children will participate in listening training in the form of an iPad app

Typically developing children with normal hearing acuity

Group Type EXPERIMENTAL

Audiovisual speech training in noise for children

Intervention Type OTHER

Children will participate in listening training in the form of an iPad app

Interventions

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Audiovisual speech training in noise for children

Children will participate in listening training in the form of an iPad app

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

Southern Connecticut State University

UNKNOWN

Sponsor Role collaborator

Haskins Laboratories

UNKNOWN

Sponsor Role collaborator

Smarty Ears

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Fernandes, M.S

Role: PRINCIPAL_INVESTIGATOR

Smarty Ears

Locations

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Southern Connecticut State University

New Haven, Connecticut, United States

Site Status

Hampton University

Hampton, Virginia, United States

Site Status

Countries

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United States

References

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Irwin J, Preston J, Brancazio L, D'angelo M, Turcios J. Development of an audiovisual speech perception app for children with autism spectrum disorders. Clin Linguist Phon. 2015 Jan;29(1):76-83. doi: 10.3109/02699206.2014.966395. Epub 2014 Oct 14.

Reference Type RESULT
PMID: 25313714 (View on PubMed)

Irwin JR, Tornatore LA, Brancazio L, Whalen DH. Can children with autism spectrum disorders "hear" a speaking face? Child Dev. 2011 Sep-Oct;82(5):1397-403. doi: 10.1111/j.1467-8624.2011.01619.x. Epub 2011 Jul 25.

Reference Type RESULT
PMID: 21790542 (View on PubMed)

Irwin JR, Brancazio L. Seeing to hear? Patterns of gaze to speaking faces in children with autism spectrum disorders. Front Psychol. 2014 May 8;5:397. doi: 10.3389/fpsyg.2014.00397. eCollection 2014.

Reference Type RESULT
PMID: 24847297 (View on PubMed)

Related Links

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http://www.smartyearsapps.com

Link to Small Business/PI on study

Other Identifiers

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3R43DC017405-01A1S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Listening2Faces

Identifier Type: -

Identifier Source: org_study_id

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