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Brain wave test could revolutionize hearing checks for babies

NCT ID NCT07392164

Diagnosis Sponsor: Susan Scollie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new prototype device that measures brain responses to speech sounds in infants. Researchers will compare brain responses between infants with normal hearing and those with hearing loss, both with and without hearing aids. The goal is to see if the device can accurately assess hearing, potentially leading to better and earlier hearing care for babies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
prototype device for speech-evoked envelope following response measurement
What this could lead to
If successful, this device could provide a more objective way to assess hearing in infants, potentially improving early detection and management of hearing loss.
What could go wrong
This is a small, early-stage study with only 20 infants, so results may not apply broadly. The device is a prototype and may not be accurate enough for clinical use yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 24 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing impairment

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dalhousie University

    Halifax, Nova Scotia, B3H4R2, Canada

  • National Acoustic Laborartory

    Macquarie Park, Sydney, NSW 2113, Australia

  • National Centre for Audiology at Western University

    London, Ontario, N6G1H1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.