Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

NCT07392164 | Not Yet Recruiting

• 1 other identifier: 122331
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

Hearing Impairment

Keywords

Hearing; Hearing impairment; Hearing aids; Evoked potentials; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Speech-Evoked Envelope Following Responses (EFRs) Agreement with Hearing Assessment

  EFR detection rates will be compared to hearing assessment results for the "Infants with normal hearing" and the "Infants with hearing loss" group for the unaided recording condition. Correlation and regression analysis will be used to look at agreement between prototype measures and the child's hearing assessment results.

  Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

Secondary Outcomes (4)

• Speech-evoked Envelope Following Response (EFR) Amplitude in Infants with Hearing Loss

  Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

• Speech-Evoked Envelope Following Responses (EFRs) Amplitude Between Normal Hearing and Hearing Loss Infants

  Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

• Speech-evoked Envelope Following Response (EFR) detection rates in Infants with Hearing Loss

  Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

• Speech-Evoked Envelope Following Responses (EFRs) Detection Rate Between Normal Hearing and Hearing Loss Infants

  Outcomes are assessed during the initial recording session (Day 1). When two sessions are required, outcome data collection is completed within 2 weeks of the first session.

Study Arms (1)

Infants with normal hearing and with hearing loss

EXPERIMENTAL

Infants with clinically confirmed normal hearing and hearing loss. Participants will undergo up to 2 recording sessions of speech-evoked envelope following responses (EFRs) using the newly developed prototype device in both unaided (for normal hearing) and aided conditions (if child has been fit with hearing aids). If applicable, hearing aid settings will be recorded; their device settings will not be altered. Hearing assessment results and acoustic measures will be obtained through chart review with caregiver consent.

Device: A newly developed prototype device for speech-evoked EFR Measurement

Interventions

A newly developed prototype device for speech-evoked EFR Measurement DEVICE

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.

Infants with normal hearing and with hearing loss

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants (3 to 24 months of age) with normal hearing who have passed their audiological diagnostic evaluation
• Infants (3 to 24 months of age) identified with hearing loss at their audiological diagnostic evaluation, whose parents have chosen spoken language as their form of communication, and who have been prescribed and fitted with a hearing aid(s).

You may not qualify if:

• Participants who have abnormal middle ear measure results or occluding ear wax will be excluded.

Sponsors & Collaborators

• Susan Scollie: lead
• Dalhousie University: collaborator

Study Sites (3)

National Acoustic Laborartory

Macquarie Park, Sydney, NSW 2113, Australia

Location

Dalhousie University

Halifax, Nova Scotia, B3H4R2, Canada

Location

National Centre for Audiology at Western University

London, Ontario, N6G1H1, Canada

Location

Related Publications (2)

• Easwar, V., Scollie, S., Lasarev, M., Urichuk, M., Aiken, S.J., Purcell, D.W. (2021). Characteristics of speech-evoked envelope following responses in infancy. Trends in Hearing. Published online doi: 10.1177/23312165211004331

  BACKGROUND

• Easwar, V., Purcell, D., Aiken, S., Parsa, V., Scollie, S. (2015). Evaluation of speech-evoked envelope following responses as an objective aided outcome measure: Effect of stimulus level, bandwidth, and amplification in adults with hearing loss. Ear and Hearing, Published online doi: 10.1097/AUD.0000000000000188.

  BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan Scollie, PhD

  Western University

  PRINCIPAL INVESTIGATOR

• David Purcell, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Scollie, PhD

CONTACT

519-661-2111; scollie@nca.uwo.ca

Krystal Beh, MClSc

CONTACT

kbeh@nca.uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: The de-identified IPD and supporting information will be available beginning immediately after publication, with no end date.
• Access Criteria: Access to individual participant data will be restricted to authorized research personnel directly involved in data collection, compilation, and analysis at Western University, Dalhousie University, and the National Acoustics Laboratories. Each site will retain identifiable information locally, including consent forms and master lists, which will not be shared. Only de-identified data will be uploaded to a secure, password-protected SharePoint system hosted by Western University for shared analysis. The industry partner (Audioscan) may receive de-identified technical output only if needed for prototype improvement. No identifiable information will be released externally, and results will be reported in aggregate form only.

Locations

CA (2); AU (1)