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Behavioural Intervention

Therapeutic Speech Device for Premature Birth

N/A

Recruiting

Led By Dean Koch

Research Sponsored by Thrive Neuromedical, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

Study Summary

This trial will test a device that helps preterm infants learn speech sounds to reduce neurosensory & developmental delays. It'll measure response differences in EEGs of infants exposed to the device vs. those hearing non-contingent maternal voice.

Who is the study for?

This trial is for preterm infants born at a gestational age of 35 weeks or more, currently aged between 32 and almost 36 weeks. It's not suitable for those with severe white matter injury, on ventilation via an endotracheal tube, taking sedative/seizure meds, with major congenital malformations or genetic hearing loss in the family.Check my eligibility

What is being tested?

The study tests a new device that helps preterm infants differentiate speech sounds by using a pacifier sensor connected to a speaker delivering their mother's voice. The effectiveness will be measured through EEG response differences.See study design

What are the potential side effects?

Since this trial involves non-invasive technology focused on auditory stimulation, side effects are minimal but may include potential overstimulation or discomfort from the use of the pacifier sensor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Sensory processing measurement by ERP recording

Secondary outcome measures

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

Intervention effect size impact by NICU background noise

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Intervention Group: Contingent exposure to recorded mother's voiceExperimental Treatment1 Intervention

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.

Group II: Control Group: Non-contingent exposure to recorded mother's voicePlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Thrive Neuromedical, LLCLead Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,268 Total Patients Enrolled

Emory UniversityOTHER

1,642 Previous Clinical Trials

2,563,699 Total Patients Enrolled

4 Trials studying Premature Birth

6,096 Patients Enrolled for Premature Birth

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental trial cater to geriatric patients?

"The study is admitting patients between 32 and 35 Weeks of age."

Answered by AI

Is my eligibility sufficient to partake in this research?

"To be eligible to enrol in this medical experiment, patients must have been born prematurely between the ages of 32 weeks and 35 weeks. The research team is planning on recruiting a total of 203 participants."

Answered by AI

Are there any slots available for individuals to participate in this experiment?

"The research data posted on clinicaltrials.gov indicates that this study is no longer seeking participants, as the trial was last updated in September 25th 2023. Despite not actively recruiting any more candidates for participation, 256 other studies are still taking partcipants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063122.