Visual-Acoustic Biofeedback for Speech Sound Disorder

(VISIT Trial)

Recruiting at 2 trial locations

Age: < 18

Sex: Female

Trial Phase: Phase 2

Sponsor: New York University

Disqualifiers: Voice disorder, Orthodontia, Hearing loss, Developmental disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

76 Participants Needed

Trial Summary

What is the purpose of this trial?

Children with speech sound disorder show diminished intelligibility in spoken communication and may thus be perceived as less capable than peers, with negative consequences for both socioemotional and socioeconomic outcomes. New technologies have the potential to transform interventions for speech sound disorder, but there is a lack of rigorous evidence to substantiate this promise. This research will meet a public health need by systematically evaluating the efficacy of visual-acoustic biofeedback intervention delivered in-person versus via telepractice. The objective of this study is to test the hypothesis that treatment incorporating visual-acoustic biofeedback can be delivered via telepractice without a significant loss of efficacy. Participants will be randomly assigned to receive identical treatment either via online telepractice or in the laboratory setting. The same software for visual-acoustic biofeedback, staRt, will be used in both conditions. Participants' progress in treatment will be evaluated based on blinded listeners' perceptual ratings of probes produced before and after treatment. Pre and post treatment evaluations will be carried out in person for all participants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Visual-Acoustic Biofeedback for Speech Sound Disorder?

Research shows that visual-acoustic biofeedback, including ultrasound biofeedback, can help improve speech in individuals with speech sound disorders. Studies have found that children with persistent speech sound disorders made significant progress after using ultrasound visual biofeedback, suggesting it can be a valuable tool in speech therapy. ^{1 2 3 4 5}

Is visual-acoustic biofeedback therapy safe for humans?

The research suggests that ultrasound visual biofeedback, a type of visual-acoustic biofeedback therapy, is considered non-invasive and safe for use in speech therapy, with no significant undesired effects reported by participants. ^{1 2 3 4 6}

What makes visual-acoustic biofeedback treatment unique for speech sound disorder?

Visual-acoustic biofeedback treatment is unique because it uses real-time visual tools like ultrasound to help individuals see and correct their tongue movements during speech, which is especially helpful for those who have difficulty with traditional auditory-based methods. This approach is non-invasive and can be more effective for people who have persistent speech sound disorders that don't respond well to standard treatments. ^{1 2 3 4 7}

Eligibility Criteria

This trial is for children with speech sound disorder, which affects their clarity of speech. The study aims to help these children improve their spoken communication through a special treatment using visual-acoustic biofeedback.

Inclusion Criteria

Must exhibit less than thirty percent accuracy, based on trained listener ratings, on a probe list eliciting /r/ in various phonetic contexts at the word level

Must have home wifi sufficient to support video calls in the event of randomization to the telepractice condition

I have a laptop or desktop computer for study sessions.

Exclusion Criteria

I have not had an epileptic seizure in the last 6 months.

I do not have non-removable braces that cross my palate.

I do not have noticeable speech difficulties.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive visual-acoustic biofeedback treatment delivered either in-person or via telepractice

10 weeks

Weekly sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Visual-acoustic biofeedback

Trial Overview The trial is testing if visual-acoustic biofeedback therapy for speech sound disorder can be just as effective when given online (telepractice) as it is in person. Children will use the staRt software and their progress will be measured by how well they speak before and after the treatment.

Participant Groups

Group I: Telepractice delivery Experimental Treatment 1 Intervention

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private, password-protected WebRTC room.

Group II: In-person delivery Active Control 1 Intervention

Participants will receive visual-acoustic biofeedback treatment from a clinician in a private room in research space at one of the two clinical research sites.

Visual-acoustic biofeedback is already approved in United States, European Union for the following indications:

Approved in United States as Visual-acoustic biofeedback therapy for:

• Speech sound disorder
• Residual speech errors
• Childhood apraxia of speech

Approved in European Union as Visual-acoustic biofeedback therapy for:

• Speech sound disorder
• Residual speech errors
• Childhood apraxia of speech

Who Is Running the Clinical Trial?

New York University

Lead Sponsor

Trials

249

Recruited

229,000+

Montclair State University

Collaborator

Trials

14

Recruited

1,200+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Syracuse University

Collaborator

Trials

54

Recruited

118,000+

Findings from Research

The study evaluated the effectiveness of diagnostic ultrasound as a visual biofeedback tool for treating seven children aged 6-11 with persistent speech sound disorders that did not respond to traditional therapies.

All children showed significant improvement in their speech sound production after the intervention, as indicated by perceptual measures and observable changes in tongue shape, highlighting the potential of ultrasound in speech therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using ultrasound visual biofeedback to treat persistent primary speech sound disorders. Cleland, J., Scobbie, JM., Wrench, AA.[2022]

This pilot randomized control trial will evaluate the feasibility of using ultrasound visual biofeedback (U-VBF) as a new treatment for improving speech in children with cleft lip and palate, comparing it to standard articulation intervention.

The study aims to enroll up to 40 children aged 4 to 16 and will assess important factors like recruitment rates and family acceptability to inform the design of a larger trial in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate. Cleland, J., Crampin, L., Campbell, L., et al.[2022]

Visual-acoustic biofeedback (VAB) treatment can effectively improve speech outcomes for individuals with speech sound difficulties, particularly in correcting distortions of the /ɹ/ sound.

Successful implementation of VAB relies on key factors such as understanding acoustic representations, selecting appropriate targets and strategies, and providing effective feedback, which together enhance speech sound acquisition and generalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. Hitchcock, ER., Ochs, LC., Swartz, MT., et al.[2023]

Real-time ultrasound scanning was used as a biofeedback therapy to help correct a persistent speech defect by allowing the subject to visualize her tongue movements during speech exercises.

Preliminary results indicate that this ultrasound technique may enhance traditional speech therapy methods, providing a valuable tool for improving articulatory accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound biofeedback for speech training. Instrumentation and preliminary results. Shawker, TH., Sonies, BC.[2019]

Ultrasound visual biofeedback treatment was effective in teaching new speech articulations to children aged 6-15 with various speech sound disorders, with 10 out of 15 participants achieving their target articulation within the first two sessions.

While the treatment showed promise for establishing new articulations, the generalization of these skills to untreated words varied significantly among participants, indicating that while effective, the approach may need further refinement for broader application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enabling New Articulatory Gestures in Children With Persistent Speech Sound Disorders Using Ultrasound Visual Biofeedback. Cleland, J., Scobbie, JM., Roxburgh, Z., et al.[2021]

In a study involving 62 participants aged around 12 years, the majority reported no concerns about using ultrasound visual feedback in speech therapy, indicating a generally positive reception of the treatment.

The most common undesired effects reported were related to the ultrasound gel (40%) and probe positioning (21%), but these were considered minor and should be balanced against the potential benefits of the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? Preston, JL., Holliman-Lopez, G., Leece, MC.[2023]

The study demonstrated that ultrasound visual biofeedback (UVB) training is highly effective in teaching speech-language pathologists (SLPs) how to assess and modify tongue configuration to help correct speech sound errors, based on a proof-of-concept involving two SLPs with no prior experience in UVB.

This research fills a gap in the literature by providing empirical evidence for the effectiveness of UVB training, suggesting it could be a valuable tool for SLPs and academic programs focused on evidence-based teaching strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Ultrasound Visual Biofeedback Training for Tongue Shape Assessment During Speech Sound Production. Campos, AR., Ristau, J.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Using ultrasound visual biofeedback to treat persistent primary speech sound disorders. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Tutorial: Using Visual-Acoustic Biofeedback for Speech Sound Training. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound biofeedback for speech training. Instrumentation and preliminary results. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Enabling New Articulatory Gestures in Children With Persistent Speech Sound Disorders Using Ultrasound Visual Biofeedback. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Do Participants Report Any Undesired Effects in Ultrasound Speech Therapy? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of an Ultrasound Visual Biofeedback Training for Tongue Shape Assessment During Speech Sound Production. [2022]