Speech PerceptionL2FNCT04473729
Improving Perception of Speech in Noise in Children With Communication Disorders
A study testing Audiovisual speech training in noise for children in people with Speech Perception, run by Smarty Ears at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech Perception
- What is being tested?
- Audiovisual speech training in noise for children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jul 2020to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hampton University
Hampton, Virginia, 23669
Southern Connecticut State University
New Haven, Connecticut, 06515
About this study
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.
Read the 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.
- Conditions
- Speech Perception
- Being tested
- Audiovisual speech training in noise for children
- Keywords
- ASD, speech in noise, Hearing Loss, speech-to-noise ratio
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual speech training in noise for childrenOther
Children will participate in listening training in the form of an iPad app
| Study group | Role | What they receive |
|---|---|---|
| Children with an autism spectrum disorder | Experimental | The intervention as described above with children with an ASD. Receives: Other: Audiovisual speech training in noise for children |
| Children with Hearing Loss | Experimental | Not described Receives: Other: Audiovisual speech training in noise for children |
| Typically developing children with normal hearing acuity | Experimental | Not described Receives: Other: Audiovisual speech training in noise for children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days a week for 4 weeks (30 minutes/day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start3 Jul 2020
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Speech PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smarty Ears
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD), Southern Connecticut State University, Haskins Laboratories
- Responsible party
- Sponsor
- Investigators
- Barbara Fernandes, M.S, Principal investigator, Smarty Ears
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473729
- Sponsor's protocol ID
- Listening2Faces
- Other IDs
- 3R43DC017405-01A1S1
- Acronym
- L2F
- Status last verified
- Aug 2021
- First submitted
- 13 Jul 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25313714Irwin 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.
PubMed 21790542Irwin 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.
PubMed 24847297
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Perception of Speech in Noise in Children With Communication Disorders
- ClinicalTrials.gov ID
- NCT04473729
- Acronym / sponsor ID
- L2F / Listening2Faces
- Conditions
- Speech Perception
- Keywords
- ASD, speech in noise, Hearing Loss, speech-to-noise ratio
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Smarty EarsIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute on Deafness and Other Communication Disorders (NIDCD), Southern Connecticut State University, Haskins Laboratories
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Children with an autism spectrum disorder | Experimental | Other: Audiovisual speech training in noise for childrenThe intervention as described above with children with an ASD. |
| 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 |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual speech training in noise for childrenChildren will participate in listening training in the form of an iPad app | Other | Children with Hearing Loss, Children with an autism spectrum disorder, Typically developing children with normal hearing acuity |
Primary outcome
Daily training performance
Time frame: 5 days a week for 4 weeks (30 minutes/day)
Daily performance level based on words correct as a function of SNR and the average SNR over the course of training for 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Results publication: PubMed 25313714Irwin 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 publication: PubMed 21790542Irwin 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 publication: PubMed 24847297Irwin 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.
- Link to Small Business/PI on studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Fernandes, M.S principal investigator
Smarty Ears
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual speech training in noise for children in people with Speech Perception, run by Smarty Ears at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily training performance (time frame: 5 days a week for 4 weeks (30 minutes/day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04473729, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.