RECRUITING Not applicable ClinicalTrials.gov

BiOfeedback, Online for Sibilant Treatment

Sponsor: Montclair State University • ClinicalTrials.gov ID: NCT07041723

Registry updated: 2026-08-31

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

The goal of this clinical trial is to evaluate the efficacy of sibilant biofeedback treatment delivered via telepractice in six children ages 8:0-17;11 who present with distortions of /s/. The main questions it aims to answer are: * Primary hypothesis: Biofeedback treatment for sibilants delivered via telepractice will produce positive gains compared to a no-treatment baseline phase. * Secondary hypothesis: Participants will experience positive changes in social-emotional well-being after receiving biofeedback treatment for sibilants as reported by the participants and their guardians. Following the initial evaluation, participants will be randomly assigned to transition from baseline to treatment at one of seven possible points, ranging from 4-10 baseline sessions in which /s/ production will be probed but not treated. All participants will then receive 20, 1-hour biofeedback treatment sessions over 10 weeks with a certified Speech-Language Pathologist via teletherapy, followed by three maintenance sessions.

Interventions

Visual-acoustic biofeedback for Sibilants (Behavioral)
Participants will view a real-time FFT spectrum and will be cued to match a visual target for /s/ where the spectral energy is concentrated to the right side of the display, primarily in the 5000-10,000 Hz region of the spectrum. Practice will occur in blocks of 10 consecutive trials on the same item (e.g., 10 /sa/), after which a new item will be addressed (e.g., 10 /se/). Within each block, the clinician will provide qualitative (knowledge of performance) feedback as prompted by the research team's custom open-source software, Challenge Point Program (CPP). The CPP software prompts clinician actions such as delivery of knowledge of performance (KP) feedback. Following each block of ten trials, the software automatically tallies the scores entered by the clinician and uses the summed scores to make adaptive changes in practice difficulty.

Eligibility criteria

Inclusion Criteria: * Age between 8;0 and 17;11 years at the time of enrollment * English as the dominant language (must have begun learning English by age 3, per parent report) * Passes pure-tone hearing screening at 30 dB hearing level * Passes brief examination of oral structure and function * Less than 30% accuracy, based on consensus across 2 trained listeners, on a probe list eliciting fricative /s, z/ in various phonetic contexts at the word level * No more than 3 sounds other than /s/ in error on the Goldman-Fristoe Test of Articulation-3 (GFTA-3) * Diagnosis of ADHD, learning disability, dyslexia, or neurodiversity is admissible if participant meets cutoff scores on evaluation day 1 * History of CAS is admissible if participant meets cutoff scores on evaluation day 1 * Braces and removable retainers are admissible * Access to a laptop or desktop computer and a quiet space for study sessions Exclusion Criteria: * Scaled score of 7 or higher on the Recalling Sentences and Formulated Sentences subtests of the Clinical Evaluation of Language Fundamentals-5 (CELF-5) * History of permanent hearing loss (temporary hearing loss due to otitis media, including recurrent OM/tubes, is admissible) * History of developmental disorder (e.g., Down syndrome, cerebral palsy) * History of major brain injury, surgery, or stroke in the past year (mild concussion is admissible) * Active diagnosis of epilepsy or other neurological disorder (permissible if well-controlled for at least 6 months) * Current diagnosis of voice or fluency disorder * Current presence of orthodontia that crosses the palate (braces and removable retainers are admissible) * Lack of access to a laptop or desktop computer and a quiet space for study sessions

Conditions

Speech Sound Disorder

Locations

Montclair State University — Bloomfield, New Jersey, United States

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment