Actively Recruiting
Phase Not Applicable
Age: 32Weeks - 35Weeks
All Genders
Healthy Volunteers
ID06063122
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
N/A
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
Researchers are evaluating a new medical device designed to improve speech sound differentiation in hospitalized preterm infants. These infants, born between 32 and 35 weeks gestation, are at high risk for developmental delays and poor language outcomes due to limited exposure to infant-directed parental speech in the NICU. The study aims to test whether infants receiving a learning intervention with contingent mother's voice triggered by their sucking show better brain responses to speech sounds compared to those hearing the same voice non-contingently. The study compares two groups: one receives 20-minute sessions of non-contingent recorded mother's voice played passively through a speaker device twice daily, and the other receives contingent exposure where the mother's voice plays only when the infant sucks on a pacifier sensor meeting a pressure threshold. The device integrates a sensor into a disposable pacifier connected to a speaker that delivers the voice at safe volume levels, designed for use in NICUs and meeting infection control standards. The intervention lasts up to 20 sessions over 3 weeks. Participants will undergo brain activity measurements using EEG before and after the intervention to assess speech sound processing. The study also explores how NICU background noise and room type affect the intervention's effectiveness. Monitoring includes stable physiological states during sessions with nurses or therapists present. The total participation time includes EEG tests and up to three weeks of intervention with follow-up assessments for brain responses.
CONDITIONS
Brief 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
You may qualify if you...
- Corrected gestational age between 32 0/7 and 35 0/7 weeks at study start
- Gestational age 35 0/7 weeks or less at birth
You will not qualify if you...
- Use of ventilation with an endotracheal tube
- Presence of major congenital malformations
- Family history of genetic hearing loss
- Use of sedative or seizure medications that might 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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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 3 weeks
Participants receive up to two 20-minute sessions per day of recorded mother's voice through a smallTalk NICU device. One group receives voice contingent on infant sucking, while the control group receives non-contingent voice exposure. The treatment is delivered during stable and receptive states over approximately 3 weeks.
Up to 40 sessions (two 20-minute sessions per day)
Follow-up
Duration - Up to 3 months after treatment
Participants undergo sensory processing assessment by ERP recording within 24 hours after the last treatment session. Additional analysis on intervention effects based on NICU background noise and room type occurs within 3 months of study enrollment completion.
1 follow-up visit for ERP testing; additional assessments may occur depending on NICU factors
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
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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