NCT05260307

Brief Summary

The purpose of this study is to investigate several approaches for improving spatial perception and speech intelligibility in multitalker listening situations for hearing-aid users. The hypotheses are that spatial perception and speech intelligibility will be improved by (1) increased high-frequency audibility, (2) speech envelope enhancement, and/or (3) appropriate sound image externalization.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Mar 2022Nov 2026

First Submitted

Initial submission to the registry

February 4, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 9, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

September 24, 2025

Status Verified

September 1, 2025

Enrollment Period

4.7 years

First QC Date

February 4, 2022

Last Update Submit

September 19, 2025

Conditions

Keywords

Hearing AidsSpeech IntelligibilitySpatial HearingCocktail PartyAudibilitySound Image ExternalizationSpeech Envelope

Outcome Measures

Primary Outcomes (8)

  • Speech intelligibility at baseline

    Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%).

    Baseline

  • Speech intelligibility post-intervention

    Speech intelligibility scores will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in percent correct (0-100%).

    Up to 4 hours

  • Speech reception threshold at baseline

    Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence).

    Baseline

  • Speech reception threshold post-intervention

    Speech reception thresholds will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in decibels (the level of the target speech relative to the masker speech needed to identify 50% of the words in a sentence).

    Up to 4 hours

  • Interaural time difference discrimination at baseline

    Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds.

    Baseline

  • Interaural time difference discrimination post-intervention

    Thresholds for the discrimination of interaural time differences in speech will be measured in a baseline condition (e.g. unaided) and in a number of hearing-aid conditions (post-intervention). Scale is in microseconds.

    Up to 4 hours

  • Externalization rating at baseline

    Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%).

    Baseline

  • Externalization rating post-intervention

    Externalization judgments for speech will be measured in a baseline condition (e.g. unaided) and in a number of different hearing-aid conditions (post-intervention). Scale is in percent (0-100%).

    Up to 4 hours

Study Arms (1)

Experimental condition

OTHER

Participants will be presented with sound stimuli under a number of experimental conditions that simulate different hearing-aid conditions.

Other: hearing aid condition

Interventions

The intervention will be a hearing aid or a modification to the sound stimulus that simulates a hearing aid configuration, style, or processing strategy.

Experimental condition

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 35 years of age
  • Audiometric thresholds that do not exceed 20 dB HL at any frequency from 250 to 8000 Hz
  • Able to provide informed consent and understand experimental instructions
  • Normal or corrected-to-normal vision
  • to 80 years of age
  • Documented sensorineural hearing loss
  • Able to provide informed consent and understand experimental instructions
  • Normal or corrected-to-normal vision

You may not qualify if:

  • Non-native speakers of English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Hearing LossSpeech Intelligibility

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpeechVerbal BehaviorCommunicationBehavior

Study Officials

  • Virginia A Best, PhD

    Boston University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Virginia A Best, PhD

CONTACT

Christine Mason

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
While participants will not be informed about the specific experimental condition being tested, certain acoustical changes may be perceptible to them and thus strict masking is impossible.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants will be tested under a number of experimental conditions that simulate different hearing aid conditions. They will act as their own control.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2022

First Posted

March 2, 2022

Study Start

March 9, 2022

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

September 24, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie results in a publication will be made publicly available.

Time Frame
The data will be made available at the time of the relevant publication.

Locations