BiOfeedback, Online for Sibilant Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Online Rotating Delivery of Perception/Production Enhanced Treatment for Rhotics

NCT06969521

Speech Sound Disorder

RECRUITING NA

staRt: Enhancing Speech Treatment With Smartphone-delivered Biofeedback

NCT04474691

Speech Sound Disorder

COMPLETED NA

Visual-acoustic Intervention With Service Delivery In-person and Via Telepractice Trial

NCT06517225

Speech Sound Disorder

RECRUITING PHASE2

Comparing Traditional and Biofeedback Telepractice Treatment for Residual Speech Errors

NCT04625062

Speech Sound Disorder

COMPLETED PHASE1

Delineation of Sensorimotor Subtypes Underlying Residual Speech Errors

NCT03736213

Speech Sound Disorder

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Study 2 will evaluate children with residual speech sound disorder affecting /s/ (n = 6). Both male and female children will be recruited. Participants must be between 8;0 and 17;11 years of age at the time of enrollment.

Randomization. Following the initial evaluation to determine eligibility, participants will be randomly assigned to transition from the baseline to the treatment condition at one of 7 possible points, ranging from 4 to 10 baseline sessions in which /s/ production will be probed but not treated. All participants will then receive 20 sessions of /s/ production training over 10 weeks, followed by 3 maintenance sessions.

Intervention Delivery. All treatment will be provided on an individual basis by a certified speech-language pathologist. Treatment will be delivered over Zoom videoconference calls using a unique password-protected room for each participant. In the beginning of each session a standard probe eliciting /s/ in various contexts at the sentence, word and syllable levels will be elicited. Following the /s/ probes, the session will consist of relatively unstructured, highly interactive prepractice for 10 minutes, which is designed to provide instruction on the phonetic requirements for /s/ and shaping strategies to transform the child's current productions into accurate /s/. The remainder of the session will elicit up to 150 syllables/words or 40 minutes of practice, whichever occurs first. 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, promoting increased fidelity in treatment implementation both within and across sites. It also enables systematic changes in practice difficulty based on participant performance, as follows: after the software presents a stimulus and the participant attempts to produce it, the clinician scores the response as 0 or 1 based on their clinical impression of an incorrect or correct production of /s/. Following each block of ten trials, the software automatically tallies the scores entered by the clinician and uses them to make adaptive changes in practice difficulty. When a participant demonstrates at least 80% cumulative accuracy at the session level, the participants will be advanced from syllable to word-level practice; if the cumulative session-level accuracy drops below 50%, the participants will be dropped back to the syllable level to decrease difficulty. In word-level practice, parameters are adjusted on a rotating basis so that as accuracy increases, either the frequency of feedback is reduced (80%-50%-20%-0%), clinician models are faded, or word shapes increase in complexity. Qualitative feedback (either biofeedback or verbal clinician feedback) will begin at 80% of trials and, contingent upon the participant's performance, will be systematically decreased to 0% .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Speech Sound Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

For all treatment sessions, the participant and SLP will meet in a secure videoconference room. Participants will be provided with a standard headset with microphone (Plantronics Blackwire C3225) to capture their voice as input to the SonaSpeech II software running the SonaMatch real time FFT function. Information about the distribution of energy across the frequency range from the FFT spectrum has been found to reliably differentiate /s/ from other fricatives; clinically, this can be translated to differentiated perceptually accurate /s/ from misarticulated productions. 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. Other aspects of the treatment protocol will follow the current research team's published guidelines for biofeedback intervention, modified for /s/ targets.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Visual acoustic biofeedback

Visual-acoustic biofeedback using the the SonaSpeech II software running the Sona Match module with the real-time FFT function.

Group Type EXPERIMENTAL

Visual-acoustic biofeedback for Sibilants

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Visual-acoustic biofeedback for Sibilants

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No