Speech-Evoked Auditory Potentials: Multisite Pediatric Evaluation

Overview

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.

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.

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.

Primary outcome measures

• 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.]

Secondary outcome measures (4)

• 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.]
• 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.]
• 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.]
• 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.]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Canada · 2 centers

• Dalhousie University — Halifax
• National Centre for Audiology at Western University — London

Australia · 1 center

• National Acoustic Laborartory — Macquarie Park

Publications

• Easwar V, Scollie S, Lasarev M, Urichuk M, Aiken SJ, Purcell DW. Characteristics of Speech-Evoked Envelope Following Responses in Infancy. Trends Hear. 2021 Jan-Dec;25:23312165211004331. doi: 10.1177/23312165211004331. PMID 34251887
• Easwar V, Purcell DW, Aiken SJ, Parsa V, Scollie SD. 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 Hear. 2015 Nov-Dec;36(6):635-52. doi: 10.1097/AUD.0000000000000199. PMID 26226606

Identifiers

NCT: NCT07392164 · 122331

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗