A device to help preterm infants differentiate speech sounds
Official title: Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants
Run by Thrive Neuromedical, LLC · NCT06063122 · Data updated 2026-11-12
This study is testing a new device that helps preterm infants learn to tell different speech sounds apart by using a pacifier that plays their mother's voice.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 32 Weeks to 35 Weeks |
| Sex | All |
| Enrollment | 203 (estimated) |
| Sponsor | Thrive Neuromedical, LLC Industry-sponsored |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Status | Recruiting |
| Started | March 8, 2024 |
| Main results expected | January 31, 2026 |
| Study ends | February 1, 2026 |
| Registry record updated | September 10, 2025 |
| Trial ID | NCT06063122 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are preterm infants aged 32 to 35 weeks at the start of the study.
✕Probably not a fit
Patients who are on ventilation with an endotracheal tube or have major congenital malformations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study aims to evaluate a novel medical device designed to enhance speech sound differentiation in hospitalized preterm infants. The device is intended for use in Level II to Level IV NICUs and operates through a pacifier equipped with a sensor that detects sucking pressure and timing, which is connected to a speaker delivering the mother's voice. By targeting infants aged 32 weeks gestational age or older, the study seeks to address the cognitive and language delays often experienced by preterm infants due to inadequate exposure to infant-directed speech. The hypothesis is that using this device will improve the infants' ability to differentiate speech sounds, potentially leading to better developmental outcomes.
Why it matters
Potential benefit: If successful, this device could significantly improve language development and cognitive outcomes for preterm infants.
How similar studies have gone: While this approach is novel, similar studies have shown promise in addressing developmental delays in preterm infants through targeted interventions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth Exclusion Criteria: * Ventilation using an endotracheal tube, major congenital malformations, family history of genetic hearing loss, and use of sedative/seizure medications (medications potentially masking ERP measured sensory processing) and severe white matter injury as it increases the likelihood of hearing deficits.
Where it's running
-
Emory University
Atlanta, Georgia, United States Recruiting -
Thrive Neuromedical, LLC
Chagrin Falls, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: Dean Koch — Thrive Neuromedical, LLC
- Study coordinator: Dean Koch
- Email: dean@smalltalk.tech
- Phone: 440-289-3656
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.