Spatial Hearing DevelopmentEarly Phase 1NCT05815537
Development of Functional Spatial Hearing in Reverberation
A Early Phase 1 study testing Low-Reverberation and High-Reverberation in people with Spatial Hearing Development, run by Father Flanagan's Boys' Home at 1 site in United States.
Trial summary
The goal of the clinical trial study (Phase 0) is to map out the developmental trajectory of functional spatial hearing abilities in reverberant environments for children with normal hearing between the ages of 6 and 18 years, and to understand the inter-relationships between the three perceptual abilities: auditory… Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatial Hearing Development
- What is being tested?
- Low-Reverberation and High-Reverberation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Mar 2026
- Phase
- Early Phase 1
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All individuals within age limits who are typically developing with normal hearing who pass 25 dB HL from 250 Hz to 8000 Hz.
Who cannot join
- Individuals who fail hearing screen as described above.
- Individuals who have a diagnosed intellectual developmental disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys Town National Research Hospital
Omaha, Nebraska, 68131
About this study
The goal of the clinical trial study (Phase 0) is to map out the developmental trajectory of functional spatial hearing abilities in reverberant environments for children with normal hearing between the ages of 6 and 18 years, and to understand the inter-relationships between the three perceptual abilities: auditory object size formation, spatial acuity, and spatial unmasking during typical development. Children are asked to perform psychoacoustic tasks when the auditory stimuli are processed to present in virtual acoustic environments (1) with no reverberation and (2) with one of the two levels of reverberation that emulate everyday indoor environments. The intervention of this clinical study is in the random assignment of one of the two reverberant environments. Researchers will compare these children with a group of normal-hearing adults to anchor matured performances.
- Conditions
- Spatial Hearing Development
- Being tested
- Low-Reverberation, High-Reverberation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-ReverberationOther
The exposure to low-reverberation is by presenting auditory stimuli to participants that are digitally processed to contain auditory cues that sound more or less reverberant, e.g., small classroom.
High-ReverberationOther
The exposure to high-reverberation is by presenting auditory stimuli to participants that are digitally processed to contain auditory cues that sound more or less reverberant, e.g., large lecture hall/auditorium.
| Study group | Role | What they receive |
|---|---|---|
| Low-Reverberation | Experimental | Participants perform psychoacoustic tasks under a low-reverberant environment and a control environment without reverberation. Receives: Other: Low-Reverberation |
| High-Reverberation | Experimental | Participants perform psychoacoustic tasks under a high-reverberant environment and a control environment without reverberation. Receives: Other: High-Reverberation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Object Size (Apparent Source Width)
Psychoacoustic measure of the smallest detectable change in width of an auditory image in degree angular span in the horizontal plane
Measured: Year 1-3
Spatial Acuity (Minimum audible angle)
Psychoacoustic measure of the smallest detectable angular separation between two auditory objects
Measured: Year 1-3
Spatial Unmasking (Minimum angular separation)
Psychoacoustic measure of the smallest angular separation to gain a target speech benefit in the presence of distracting speech maskers
Measured: Year 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Jan 2024
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spatial Hearing DevelopmentStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two arms in the exposure of reverberation for participants. For children (n1=45) and adults (n1=15) assigned to Arm 1, they receive a non-reverberant environment (control) and a low-reverberant environment (intervention A). For children (n2 = 45) and adults (n2 = 15) assigned to Arm 2, they receive the same non-reverberant environment (control) and a high-reverberant environment (intervention B). Both arms of children and adults enrolled perform the same psychoacoustic tasks for outcome assessments.
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Father Flanagan's Boys' Home
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Peng, Father Flanagan's Boys' Home
- Investigators
- Z. Ellen Peng, Principal investigator, Father Flanagan's Boys' Home
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815537
- Sponsor's protocol ID
- BoysTown
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Functional Spatial Hearing in Reverberation
- ClinicalTrials.gov ID
- NCT05815537
- Acronym / sponsor ID
- BoysTown
- Conditions
- Spatial Hearing Development
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Father Flanagan's Boys' HomeUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 18 Apr 2023 (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 the clinical trial study (Phase 0) is to map out the developmental trajectory of functional spatial hearing abilities in reverberant environments for children with normal hearing between the ages of 6 and 18 years, and to understand the inter-relationships between the three perceptual abilities: auditory object size formation, spatial acuity, and spatial unmasking during typical development. Children are asked to perform psychoacoustic tasks when the auditory stimuli are processed to present in virtual acoustic environments (1) with no reverberation and (2) with one of the two levels of reverberation that emulate everyday indoor environments. The intervention of this clinical study is in the random assignment of one of the two reverberant environments. Researchers will compare these children with a group of normal-hearing adults to anchor matured performances.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two arms in the exposure of reverberation for participants. For children (n1=45) and adults (n1=15) assigned to Arm 1, they receive a non-reverberant environment (control) and a low-reverberant environment (intervention A). For children (n2 = 45) and adults (n2 = 15) assigned to Arm 2, they receive the same non-reverberant environment (control) and a high-reverberant environment (intervention B). Both arms of children and adults enrolled perform the same psychoacoustic tasks for outcome assessments.
| Arm | Type | Receives |
|---|---|---|
| Low-Reverberation | Experimental | Other: Low-ReverberationParticipants perform psychoacoustic tasks under a low-reverberant environment and a control environment without reverberation. |
| High-Reverberation | Experimental | Other: High-ReverberationParticipants perform psychoacoustic tasks under a high-reverberant environment and a control environment without reverberation. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All individuals within age limits who are typically developing with normal hearing who pass 25 dB HL from 250 Hz to 8000 Hz.
Key exclusion criteria (2 listed)
- Individuals who fail hearing screen as described above.
- Individuals who have a diagnosed intellectual developmental disability
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 |
|---|---|---|
| Low-ReverberationThe exposure to low-reverberation is by presenting auditory stimuli to participants that are digitally processed to contain auditory cues that sound more or less reverberant, e.g., small classroom. | Other | Low-Reverberation |
| High-ReverberationThe exposure to high-reverberation is by presenting auditory stimuli to participants that are digitally processed to contain auditory cues that sound more or less reverberant, e.g., large lecture hall/auditorium. | Other | High-Reverberation |
Primary outcome
Auditory Object Size (Apparent Source Width)
Time frame: Year 1-3
Psychoacoustic measure of the smallest detectable change in width of an auditory image in degree angular span in the horizontal plane
Spatial Acuity (Minimum audible angle)
Time frame: Year 1-3
Psychoacoustic measure of the smallest detectable angular separation between two auditory objects
Spatial Unmasking (Minimum angular separation)
Time frame: Year 1-3
Psychoacoustic measure of the smallest angular separation to gain a target speech benefit in the presence of distracting speech maskers
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 28 Apr 2026.
Related trials for Spatial Hearing Development
Recruiting
Perceptual Evaluation and Rehabilitation System Development for Congenital Hearing Loss
Congenital Hearing Loss, Gene Therapy
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.
Z. Ellen Peng principal investigator
Father Flanagan's Boys' Home
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Low-Reverberation and High-Reverberation in people with Spatial Hearing Development, run by Father Flanagan's Boys' Home 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 1 inclusion and 2 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 28 Apr 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Auditory Object Size (Apparent Source Width) (time frame: Year 1-3). The study lists 3 primary outcomes in all. 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 28 Apr 2026.