Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical study is to test a new, novel medical device designed to improve speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Preterm born infants are at high risk for neurosensory impairments and developmental delays. In the NICU, infants are often deprived of infant-directed parental speech because of numerous challenges to parental visitation, resulting in reduced differentiation of speech sounds, altered brain structure and poor language outcomes. The study will explore the effectiveness of a novel medical device designed for infant learning through contingent sucking on a pacifier equipped with a sensor for suck pressure/timing, connected to a speaker that delivers mother's voice. The study will test the hypothesis that there will be a greater response difference between speech sounds on EEG, for infants receiving the suck-contingent mother's voice intervention than for infants hearing the same amount of non-contingent mother's voice from a speaker device.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 8 months
Healthy Volunteers: t
View:

• CGA 32 0/7-35 0/7 weeks at study start, and GA 35 0/7 weeks at birth

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Ohio
Thrive Neuromedical, LLC
NOT_YET_RECRUITING
Chagrin Falls
Contact Information
Primary
Dean Koch
dean@smalltalk.tech
440-289-3656
Time Frame
Start Date: 2024-03-08
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 203
Treatments
Sham_comparator: Control Group: Non-contingent exposure to recorded mother's voice
Participants will receive 20 minutes of non-contingent recorded mother' voice during two 20-minute sessions, with a maximum of 2 sessions per day. Recordings are played through the smallTalk speaker device in passive mode, which limits play time to 20-minute exactly and volume to 45 dB in the A-weighted scale as per American Academy of Pediatrics recommendations. For these sessions, the therapist will remain at bedside with the infant and the device, as if they were administering the intervention. Nurses do not typically remain at bedside for the procedure due to workload issues and the low risk of the intervention.
Experimental: Intervention Group: Contingent exposure to recorded mother's voice
Participants will receive 20 minutes of contingent recorded mother' voice also at 45 dBA, during two 20-minute sessions, with a maximum of 2 sessions per day. The smallTalk Active system integrates a wireless, lightweight and sealed sensor unit that securely fits into a Philips NICU Soothie pacifier. The speaker device is factory set to communicate constantly with the sensor unit, and to only deliver a predetermined 10 seconds of recorded parent's voice upon detection of a suck that meets a pressure threshold, which is automatically set by the speaker device.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), Emory University
Leads: Thrive Neuromedical, LLC

This content was sourced from clinicaltrials.gov