Actively Recruiting

Phase Not Applicable
Age: 32Weeks - 35Weeks
All Genders
Healthy Volunteers
NCT06063122

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

Led by Thrive Neuromedical, LLC · Updated on 2025-09-10

203

Participants Needed

2

Research Sites

99 weeks

Total Duration

On this page

Sponsors

T

Thrive Neuromedical, LLC

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 32Weeks - 35Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Corrected gestational age between 32 0/7 and 35 0/7 weeks at study start
  • Gestational age at birth between 32 0/7 and 35 0/7 weeks
Not Eligible

You will not qualify if you...

  • Ventilation using an endotracheal tube
  • Major congenital malformations
  • Family history of genetic hearing loss
  • Use of sedative or seizure medications that may affect sensory processing
  • Severe white matter injury increasing risk of hearing deficits

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Thrive Neuromedical, LLC

Chagrin Falls, Ohio, United States, 44023

Not Yet Recruiting

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Research Team

D

Dean Koch

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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