Clinical trial NCT04473729: Improving Perception of Speech in Noise in Children With Communication Disorders
Official title: Improving Perception of Speech in Noise in Children With Communication Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Speech Perception
Keywords: ASD
speech in noise
Hearing Loss
speech-to-noise ratio
Lead sponsor: Smarty Ears
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Southern Connecticut State University
name: Haskins Laboratories
First posted: 2020-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Daily training performance
timeFrame: 5 days a week for 4 weeks (30 minutes/day)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Southern Connecticut State University
state: Connecticut
city: Hampton
country: United States
facility: Hampton University
state: Virginia
Study officials:
affiliation: Smarty Ears
name: Barbara Fernandes, M.S
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.