Hearing LossNCT05653999
Assessing Speech Perception and Amplification Benefit During Infancy
An observational study of Hearing Loss and Children With Hearing Differences, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing. Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification… Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Children With Hearing Differences, Amplification
- What is being tested?
- Hearing Aids
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2023to 28 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants between 6 and 36 months of age (inclusively) will be be enrolled in either the normal hearing or hearing loss cohort based on hearing status. Infants will be recruited from the community as well as through established clinical relationships with the principal investigator at Children's Hospital Colorado Audiology Centers.
Who may be able to join
- Children between the ages of 6 months and 36 months (inclusive) at the time of enrollment.
- English is the primary spoken language in the home
- Demonstrated ability to complete a conditioned head turn via visual reinforcement audiometry (VRA)
- If normal hearing
- -Normal hearing sensitivity bilaterally
- If Hearing Loss
Show all 9Show fewer
- Children with diagnosis of bilateral sensorineural hearing ranging from mild to severe
- Children currently using hearing aids
- Children currently enrolled in intervention
Who cannot join
- Children born earlier than 35 weeks gestation
- Children with abnormal tympanometry on the day of testing
- Children with concerns of secondary disabilities
- Children with Auditory Neuropathy
- Concerns of hearing loss in normal hearing children
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine - Speech Perception Over Time Lab
Aurora, Colorado, 80045
About this study
The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing.
Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification (i.e., aided condition) compared to when tested without amplification (i.e., unaided condition). Infants fit with optimally programmed amplification will perform similarly to the infants with typical hearing on speech discrimination tasks.
- Being tested
- Hearing Aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing AidsDevice
Hearing aids will be used by infants with a diagnosed sensorineural hearing loss.
| Study group | Role | What they receive |
|---|---|---|
| Normal Hearing | Group 1 will consist of approximately 20 infants with normal hearing. This cohort will have passed their newborn hearing screenings and will pass audiologic measurements on the day of testing. Audiologic measurements include tympanometry to determine middle ear function and otoacoustic emissions testing to determine cochlear integrity. | |
| Hearing Loss | Group 2 will consist of approximately 20 infants with diagnosed bilateral sensorineural hearing loss ranging from mild to severe. These infants will also pass audiologic measures on the day of testing (tympanometry as described in group 1), currently use bilateral air-conduction hearing aids, and are enrolled in early intervention services. Receives: Device: Hearing Aids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Speech Perception
To measure speech perception ability, infants are trained to complete a task in response to a change in a speech sound played over a speaker. Scores are given in d' (or equivalent) and are calculated from both true and false responses. Scores can range from 0.97 and 3.00. Scores above 1.2 are considered significantly above chance indicating successful perception of speech contrasts. To separate issues such as speech discrimination abilities versus proper conditioning, if a child is unable to discriminate a speech contrast (e.g., /ba-da/ or /sa-sha/) testing will transition to the 'easier' speech contrast /a-i/. If the child can discriminate between /a-i/, the investigators will repeat the previously tested contrast. Upon completion of this contrast the next contrast in will be assessed based on randomization ordering. If either contrast was not assessed/the child did not reach criterion, the participant will be rescheduled within 1 month, pending subject factors.
Measured: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
Secondary outcomes (1)
Aided Behavioral Speech Perception Improvement
Scores are measured from 0 to 2.03. Higher scores indicate greater benefit from hearing aid use in the hearing loss cohort.
Measured: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start10 Mar 2023
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Sonova AG
- Responsible party
- Sponsor
- Investigators
- Kristin M Uhler, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653999
- Sponsor's protocol ID
- 22-2169
- Status last verified
- May 2025
- First submitted
- 2 Dec 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The investigators will review requests for de-identified data and review with appropriate regulatory bodies.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Speech Perception and Amplification Benefit During Infancy
- ClinicalTrials.gov ID
- NCT05653999
- Acronym / sponsor ID
- 22-2169
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Sonova AG
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to compare aided and unaided speech discrimination among infants with hearing loss and a cohort of infants with typical hearing.
Working Hypothesis: Among this group of infants with hearing loss, performance will be significantly better when infants are tested while using amplification (i.e., aided condition) compared to when tested without amplification (i.e., unaided condition). Infants fit with optimally programmed amplification will perform similarly to the infants with typical hearing on speech discrimination tasks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Hearing | – | –Group 1 will consist of approximately 20 infants with normal hearing. This cohort will have passed their newborn hearing screenings and will pass audiologic measurements on the day of testing. Audiologic measurements include tympanometry to determine middle ear function and otoacoustic emissions testing to determine cochlear integrity. |
| Hearing Loss | – | Device: Hearing AidsGroup 2 will consist of approximately 20 infants with diagnosed bilateral sensorineural hearing loss ranging from mild to severe. These infants will also pass audiologic measures on the day of testing (tympanometry as described in group 1), currently use bilateral air-conduction hearing aids, and are enrolled in early intervention services. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants between 6 and 36 months of age (inclusively) will be be enrolled in either the normal hearing or hearing loss cohort based on hearing status. Infants will be recruited from the community as well as through established clinical relationships with the principal investigator at Children's Hospital Colorado Audiology Centers.
Key inclusion criteria (9 listed)
- Children between the ages of 6 months and 36 months (inclusive) at the time of enrollment.
- English is the primary spoken language in the home
- Demonstrated ability to complete a conditioned head turn via visual reinforcement audiometry (VRA)
- If normal hearing
- -Normal hearing sensitivity bilaterally
Key exclusion criteria (5 listed)
- Children born earlier than 35 weeks gestation
- Children with abnormal tympanometry on the day of testing
- Children with concerns of secondary disabilities
- Children with Auditory Neuropathy
- Concerns of hearing loss in normal hearing children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing AidsHearing aids will be used by infants with a diagnosed sensorineural hearing loss. | Device | Hearing Loss |
Primary outcome
Behavioral Speech Perception
Time frame: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
To measure speech perception ability, infants are trained to complete a task in response to a change in a speech sound played over a speaker. Scores are given in d' (or equivalent) and are calculated from both true and false responses. Scores can range from 0.97 and 3.00. Scores above 1.2 are considered significantly above chance indicating successful perception of speech contrasts. To separate issues such as speech discrimination abilities versus proper conditioning, if a child is unable to discriminate a speech contrast (e.g., /ba-da/ or /sa-sha/) testing will transition to the 'easier' speech contrast /a-i/. If the child can discriminate between /a-i/, the investigators will repeat the previously tested contrast. Upon completion of this contrast the next contrast in will be assessed based on randomization ordering. If either contrast was not assessed/the child did not reach criterion, the participant will be rescheduled within 1 month, pending subject factors.
1 secondary outcome
Aided Behavioral Speech Perception Improvement
Time frame: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided. The investigators will review requests for de-identified data and review with appropriate regulatory bodies.
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Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin M Uhler, PhD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Children With Hearing Differences, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Speech Perception (time frame: Through study completion, up to 6 weeks pending subject factors (e.g., fatigue, otitis media)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.