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NOT YET RECRUITING
NCT07392164
NA

Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

Sponsor: Susan Scollie

View on ClinicalTrials.gov

Summary

The goal of this study is to evaluate the sensitivity of a newly-developed prototype device in its ability to measure brain responses to speech sounds in an infant population. The main research questions are: 1) Is the prototype sensitive to brain response differences from infants with hearing loss with and without hearing aids? and 2) How do the measured brain responses from infants with hearing loss compare to infants with normal hearing who are the same age? Participants will have their brain responses measured using the prototype in response to average-level non-sense speech sounds across 1 to 2 sessions in a "no-hearing aids" condition. Participants with hearing loss who are already fit with hearing aids will additionally undergo a "with hearing aids" recording condition.

Key Details

Gender

All

Age Range

3 Months - 24 Months

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-03

Completion Date

2026-12

Last Updated

2026-02-06

Healthy Volunteers

Yes

Interventions

DEVICE

A newly developed prototype device for speech-evoked EFR Measurement

Speech-evoked envelope following responses (EFRs) are measured using the newly developed clinical prototype to objectively assess auditory responses. Surface electrodes are placed on the head, a non-sense speech stimulus is presented at an average level, and EFRs are recorded for 15-30 minutes while patient sleeps or is at rest.

Locations (3)

National Acoustic Laborartory

Macquarie Park, Sydney, Australia

Dalhousie University

Halifax, Nova Scotia, Canada

National Centre for Audiology at Western University

London, Ontario, Canada