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NCT03736213 · ClinicalTrials.gov registry record · Phase 1
Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors
A Phase 1 study, sponsored by New York University.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT03736213 is a Phase 1 study that has completed, run by New York University. The registered enrollment target is 7 participants.
The verdict
NCT03736213, a Phase 1 study, has completed, sponsored by New York University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Children with speech sound disorder show diminished accuracy and intelligibility in spoken communication and may thus be perceived as less capable or intelligent than peers, with negative consequences for both socioemotional and socioeconomic outcomes. While most speech errors resolve by the late school-age years, between 2-5% of speakers exhibit residual speech errors (RSE) that persist through adolescence or even adulthood, reflecting about 6 million cases in the US. Both affected children/families and speech-language pathologists (SLPs) have highlighted the critical need for research to identify more effective forms of treatment for children with RSE. In a series of single-case experimental studies, research has found that treatment incorporating technologically enhanced sensory feedback (visual-acoustic biofeedback, ultrasound biofeedback) can improve speech in individuals with RSE who have not responded to previous intervention. Further research is needed to understand heterogeneity across individuals in the magnitude of response to biofeedback treatment. The overall objective of this proposal is to conduct clinical research that will guide the evidence-based management of RSE while also providing novel insights into the sensorimotor underpinnings of speech. The central hypothesis is that individual deficit profiles will predict relative response to visual-acoustic vs ultrasound biofeedback. From the larger population of children with RSE evaluated as part of C-RESULTS-RCT (Correcting Residual Errors With Spectral, Ultrasound, Traditional Speech Therapy Randomized Controlled Trial), a subset of 8 children will be selected who show a deficit in one domain (auditory or somatosensory) and intact perception in the other. Single-case methods will be used to test the hypothesis that sensory deficit profiles differentially predict response to visual-acoustic vs ultrasound biofeedback.
Interventions
- BEHAVIORAL Visual-acoustic biofeedback
- BEHAVIORAL Ultrasound biofeedback
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03736213
The ClinicalTrials.gov registry entry for NCT03736213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York University, which has 83 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Visual-acoustic biofeedback is the first listed.
NCT03736213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03736213 about?
NCT03736213 is a clinical study titled "Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors". Children with speech sound disorder show diminished accuracy and intelligibility in spoken communication and may thus be perceived as less capable or intelligent than peers, with negative consequences for both socioemotional and socioeconomic outcomes. While most speech errors resolve by the late sc...
What is the current status of trial NCT03736213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2019-03-01. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT03736213?
The interventions under investigation include: Visual-acoustic biofeedback (BEHAVIORAL), Ultrasound biofeedback (BEHAVIORAL).
Who is sponsoring clinical trial NCT03736213?
This trial is sponsored by New York University, which has 83 total clinical trials registered on ClinicalTrials.gov.
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