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

NCT06063122 | Recruiting DMC FDA Device

• 2 other identifiers: 2024011R44DC020684-01A1
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Premature Birth

Keywords

preterm; premature; NICU; neonatal

Outcome Measures

Primary Outcomes (1)

• Sensory processing measurement by ERP recording

  A high-density array of 128 electrodes embedded in soft sponges (high-density 64-electrode waveguard™ net, ANT Neuro, Hengelo, Netherlands) will be used to record ERPs with a sampling rate of 1000 Hz, filters set to 0.1-400 Hz. Recording of brainwaves will be controlled by eego™mylab system (v. 9.2, ANT Neuro, Hengelo, Netherlands). E-Prime (v. 4.0, PST, Inc., Pittsburgh, PA) software will control stimulus delivery. The stimuli will be presented at 60 dBA. The ERP speech sound paradigm included a computer-generated woman's voicing one of six syllables (/ba/, /da/, /ga/, /bu/, /du/, /gu/) randomly and at random intertrial intervals for a total of 25 trials per syllables over 7-10 minutes. Inter-trial intervals will be varied between 1600ms and 2600ms. All stimuli are presented thus to prevent habituation.

  Initial ERP Test is performed 2 days prior to intervention. Intervention timeframe is 20 sessions across 3 weeks. ERP Test is repeated within 24 hours of the last session.

Secondary Outcomes (2)

• Intervention effect size impact by NICU background noise

  Within 3 months of the full enrollment of study, we will assess if the primary outcome measure is impacted by the level of NICU background noise.

• Intervention effect size by NICU room type (private or semi-private/open bay)

  Within 3 months of the full enrollment of study, we will assess if the primary outcome measure is impacted by the NICU room type

Study Arms (2)

Control Group: Non-contingent exposure to recorded mother's voice

SHAM COMPARATOR

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.

Device: smallTalk NICU Active

Intervention Group: Contingent exposure to recorded mother's voice

EXPERIMENTAL

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.

Device: smallTalk NICU Active

Interventions

smallTalk NICU Active DEVICE

The novel smallTalk NICU Active product design allows a disposable pacifier (equipped with the smallTalk sensor) to act as an infant-controlled mechanism for administration of developmentally appropriate parental voice, delivered by the NICU-safe speaker contingent upon the infant suck strength meeting an individually calibrated threshold.

Control Group: Non-contingent exposure to recorded mother's voice; Intervention Group: Contingent exposure to recorded mother's voice

Eligibility Criteria

• Age: 32 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thrive Neuromedical, LLC: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Emory University: collaborator

Study Sites (2)

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Thrive Neuromedical, LLC

Chagrin Falls, Ohio, 44023, United States

NOT YET RECRUITING

Related Publications (1)

• Institute of Medicine (US) Committee on Understanding Premature Birth and Assuring Healthy Outcomes; Behrman RE, Butler AS, editors. Preterm Birth: Causes, Consequences, and Prevention. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11362/

  PMID: 20669423 BACKGROUND

Related Links

• World Health Organization report: Born Too Soon: Decade of Action on Preterm Birth
• March of Dimes Report: Long Term Health Effects of Preterm Birth

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dean Koch

  Thrive Neuromedical, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean Koch

CONTACT

440-289-3656; dean@smalltalk.tech

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: nurses/physicians treating the patient and the personnel collecting the outcomes data are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial with double blind

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 2, 2023
• Study Start: March 8, 2024
• Primary Completion: January 31, 2026
• Study Completion: February 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Upon completion of all study analysis
• Access Criteria: All reasonable requests from qualified scientists for unique research resources (protocols and expertise) developed with NIH funds for research purposes will be honored. We will respond to requests in a timely manner. We will adhere to the NIH Grant Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources Principle and Guidelines for Recipients of NIH Grants and Contracts. There is no unique biological information that could be made available to the scientific community. Data sharing will be made available by publishing articles in scientific publication, presenting research findings at scientific meetings, and by responding directly to data requests by other investigators. De-identified assessment data will be retained in REDCap and these data will be made available to other investigators who make specific inquiry for a reasonable purpose.

Locations

US (2)