NCT07041723 BiOfeedback, Online for Sibilant Treatment
| NCT ID | NCT07041723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montclair State University |
| Condition | Speech Sound Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-07-30 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6 participants in total. It began in 2025-07-30 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07041723 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 17 Years, studying Speech Sound Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07041723 currently recruiting?
Yes, NCT07041723 is actively recruiting participants. Contact the research team at hitchcocke@montclair.edu for enrollment information.
Where is the NCT07041723 trial being conducted?
This trial is being conducted at Bloomfield, United States.
Who is sponsoring the NCT07041723 clinical trial?
NCT07041723 is sponsored by Montclair State University. The trial plans to enroll 6 participants.