Development of Functional Spatial Hearing in Reverberation

NCT05815537 | Completed Early Phase 1

• 1 other identifier: BoysTown
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (3)

• 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

  Year 1-3

• Spatial Acuity (Minimum audible angle)

  Psychoacoustic measure of the smallest detectable angular separation between two auditory objects

  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

  Year 1-3

Study Arms (2)

Low-Reverberation

EXPERIMENTAL

Participants perform psychoacoustic tasks under a low-reverberant environment and a control environment without reverberation.

Other: Low-Reverberation

High-Reverberation

EXPERIMENTAL

Participants perform psychoacoustic tasks under a high-reverberant environment and a control environment without reverberation.

Other: High-Reverberation

Interventions

Low-Reverberation OTHER

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.

Low-Reverberation

High-Reverberation OTHER

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.

High-Reverberation

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All individuals within age limits who are typically developing with normal hearing who pass 25 dB HL from 250 Hz to 8000 Hz.

You may not qualify if:

• Individuals who fail hearing screen as described above.
• Individuals who have a diagnosed intellectual developmental disability

Sponsors & Collaborators

• Father Flanagan's Boys' Home: lead

Study Sites (1)

Boys Town National Research Hospital

Omaha, Nebraska, 68131, United States

Location

Study Officials

• Z. Ellen Peng

  Father Flanagan's Boys' Home

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: 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.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: January 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)