Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation (SEFR)

January 29, 2026 updated by: Susan Scollie
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In addition to the listed collaborator sites under the "sponsors and collaborators" section, this study is conducted in collaboration with the National Acoustic Laboratories (NAL), Australia, who serve as an international clinical research site contributing to data collection and scientific expertise in pediatric audiology. The prototype is being provided by Audioscan, Dorchester, ON, Canada.

Additionally, the newly developed clinical prototype device is not a U.S. FDA-regulated device. ClinicalTrials.gov registration is being completed as a prerequisite for Health Canada's investigational testing of medical devices, as outlined in Health Canada's 2007 Notice concerning registration and public disclosure of clinical trial information. The application number for Health Canada's investigational testing authorization is 389562.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Sydney
      • Macquarie Park, Sydney, Australia, NSW 2113
        • National Acoustic Laborartory
        • Contact:
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H4R2
        • Dalhousie University
        • Contact:
        • Principal Investigator:
          • Steven Aiken, PhD
        • Sub-Investigator:
          • Michel Comeau, MSc
    • Ontario
      • London, Ontario, Canada, N6G1H1
        • National Centre for Audiology at Western University
        • Principal Investigator:
          • Susan Scollie, PhD
        • Contact:
        • Principal Investigator:
          • David Purcell, PhD
        • Sub-Investigator:
          • Krystal Beh, MClSc
        • Sub-Investigator:
          • Bavadharani Venkatesan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Infants (3 to 24 months of age) with normal hearing who have passed their audiological diagnostic evaluation
  2. 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).

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infants with normal hearing and with hearing loss
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech-Evoked Envelope Following Responses (EFRs) Agreement with Hearing Assessment
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech-evoked Envelope Following Response (EFR) Amplitude in Infants with Hearing Loss
Time Frame: 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.
EFR amplitudes will be compared between the aided and unaided conditions of the "Infants with hearing loss" group. Repeated measures ANOVA and post-hoc paired t-tests will be used for data analysis.
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
Time Frame: 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.
EFR amplitudes will be compared between the "Infants with normal hearing" and the "Infants with hearing loss" groups. EFR amplitude will also be compared between groups by deriving a normal range of measurement (from normal hearing infants) and characterizing whether measures from infants with hearing loss are or are not within that range. This is a descriptive, not inferential, analysis that is mainly used to aid in interpretation of the nature of the response, so inferential statistics are not proposed.
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
Time Frame: 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.
EFR detection rates will be compared between the aided and unaided conditions of the "Infants with hearing loss" group. Repeated measures ANOVA and post-hoc paired t-tests will be used for data analysis.
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
Time Frame: 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.
EFR detection rate will be compared between the "Infants with normal hearing" and the "Infants with hearing loss" groups. EFR detection rate will also be compared between groups by deriving a normal range of measurement (from normal hearing infants) and characterizing whether measures from infants with hearing loss are or are not within that range. This is a descriptive, not inferential, analysis that is mainly used to aid in interpretation of the nature of the response, so inferential statistics are not proposed.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Susan Scollie

Collaborators

Dalhousie University

Investigators

  • Principal Investigator: Susan Scollie, PhD, Western University
  • Principal Investigator: David Purcell, PhD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 122331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For the reasons of transparency and education, it is strongly encouraged by many medical journals and other authorities to publish the anonymized data from clinical studies for public use. This data is visible to researchers or the general public after the study is over. Researchers may use this data to improve knowledge about brain responses to speech sounds.

We will publish the following anonymized data from this study: audiogram, middle ear analysis, speech test scores, and auditory evoked potentials. Note that there will be NO personal identifiers in this list.

IPD Sharing Time Frame

The de-identified IPD and supporting information will be available beginning immediately after publication, with no end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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