Improving Perception of Speech in Noise in Children With Communication Disorders

NCT04473729 | Completed

• 2 other identifiers: Listening2Faces3R43DC017405-01A1S1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Speech Perception

Keywords

ASD; speech in noise; Hearing Loss; speech-to-noise ratio

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

Children with an autism spectrum disorder

EXPERIMENTAL

The intervention as described above with children with an ASD.

Other: Audiovisual speech training in noise for children

Children with Hearing Loss

EXPERIMENTAL

Other: Audiovisual speech training in noise for children

Typically developing children with normal hearing acuity

EXPERIMENTAL

Other: Audiovisual speech training in noise for children

Interventions

Audiovisual speech training in noise for children OTHER

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

Children with Hearing Loss; Children with an autism spectrum disorder; Typically developing children with normal hearing acuity

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Smarty Ears: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Southern Connecticut State University: collaborator
• Haskins Laboratories: collaborator

Study Sites (2)

Southern Connecticut State University

New Haven, Connecticut, 06515, United States

Location

Hampton University

Hampton, Virginia, 23669, United States

Location

Related 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.

  PMID: 25313714 RESULT

• 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.

  PMID: 21790542 RESULT

• 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.

  PMID: 24847297 RESULT

Related Links

• Link to Small Business/PI on study

MeSH Terms

Conditions

Hearing Loss

Interventions

Noise

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Officials

• Barbara Fernandes, M.S

  Smarty Ears

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: July 16, 2020
• Study Start: July 3, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)