Improving Perception of Speech in Noise in Children With Communication Disorders (L2F)
Primary Purpose
Speech Perception
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Audiovisual speech training in noise for children
Sponsored by
About this trial
This is an interventional treatment trial for Speech Perception focused on measuring ASD, speech in noise, Hearing Loss, speech-to-noise ratio
Eligibility Criteria
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).
Sites / Locations
- Southern Connecticut State University
- Hampton University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Children with an autism spectrum disorder
Children with Hearing Loss
Typically developing children with normal hearing acuity
Arm Description
The intervention as described above with children with an ASD.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04473729
First Posted
July 13, 2020
Last Updated
August 27, 2021
Sponsor
Smarty Ears
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD), Southern Connecticut State University, Haskins Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT04473729
Brief Title
Improving Perception of Speech in Noise in Children With Communication Disorders
Acronym
L2F
Official Title
Improving Perception of Speech in Noise in Children With Communication Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 3, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smarty Ears
Collaborators
National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD), Southern Connecticut State University, Haskins Laboratories
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Speech Perception
Keywords
ASD, speech in noise, Hearing Loss, speech-to-noise ratio
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children with an autism spectrum disorder
Arm Type
Experimental
Arm Description
The intervention as described above with children with an ASD.
Arm Title
Children with Hearing Loss
Arm Type
Experimental
Arm Title
Typically developing children with normal hearing acuity
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Audiovisual speech training in noise for children
Intervention Description
Children will participate in listening training in the form of an iPad app
Primary Outcome Measure Information:
Title
Daily training performance
Description
Daily performance level based on words correct as a function of SNR and the average SNR over the course of training for 4 weeks
Time Frame
5 days a week for 4 weeks (30 minutes/day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Fernandes, M.S
Organizational Affiliation
Smarty Ears
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Connecticut State University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06515
Country
United States
Facility Name
Hampton University
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23669
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25313714
Citation
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.
Results Reference
result
PubMed Identifier
21790542
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.
Results Reference
result
PubMed Identifier
24847297
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.
Results Reference
result
Links:
URL
http://www.smartyearsapps.com
Description
Link to Small Business/PI on study
Learn more about this trial
Improving Perception of Speech in Noise in Children With Communication Disorders
We'll reach out to this number within 24 hrs