NCT Number: NCT07392164
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.
Trial opening soon.
Get Notified3 month–24 month
All sexes
Interventional
Not applicable
National Acoustic Laborartory, Macquarie Park, Sydney, Australia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants who have abnormal middle ear measure results or occluding ear wax will be excluded.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Susan Scollie
Other
Acronym: SEFR
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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