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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04473729
Other study ID # Listening2Faces
Secondary ID 3R43DC017405-01A
Status Completed
Phase N/A
First received
Last updated
Start date July 3, 2020
Est. completion date May 31, 2021

Study information

Verified date August 2021
Source Smarty Ears
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 31, 2021
Est. primary completion date May 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Audiovisual speech training in noise for children
Children will participate in listening training in the form of an iPad app

Locations

Country Name City State
United States Hampton University Hampton Virginia
United States Southern Connecticut State University New Haven Connecticut

Sponsors (5)

Lead Sponsor Collaborator
Smarty Ears Haskins Laboratories, National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health (NIH), Southern Connecticut State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Daily training performance 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)
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