Development of Functional Spatial Hearing in Reverberation

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 Overview

• Status: Recruiting
• Conditions: Spatial Hearing Development
• Intervention / Treatment: Other: Low-Reverberation; Other: High-Reverberation

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Z. Ellen Peng, PhD; Phone Number: 531-355-6975; Email: ellen.peng@boystown.org

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Recruiting
      • Boys Town National Research Hospital
      • Contact: Z. Ellen Peng, PhD; Phone Number: 531-355-6975; Email: ellen.peng@boystown.org
      • Principal Investigator: Z. Ellen Peng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Reverberation; Participants perform psychoacoustic tasks under a low-reverberant environment and a control environment without reverberation.	Other: Low-Reverberation; 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.
Experimental: High-Reverberation; Participants perform psychoacoustic tasks under a high-reverberant environment and a control environment without reverberation.	Other: High-Reverberation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Father Flanagan's Boys' Home
• Investigators: Principal Investigator: Z. Ellen Peng, Father Flanagan's Boys' Home

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: BoysTown

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No