NCT03666676

Brief Summary

The purpose of this study is to better understand the sensitivity of listeners to the fast changes in frequency or amplitude of sounds that occur in speech. The investigators are studying ways to manipulate these aspects of sounds in an effort to make speech sounds more clear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 9, 2020

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 29, 2025

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4.1 years

First QC Date

September 8, 2018

Results QC Date

October 15, 2024

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pure-tone Average Thresholds

    Hearing thresholds, average across test frequencies from 250 to 4000 Hz and averaged across the two ears.

    6 months

  • F1 Discrimination Threshold

    Discrimination threshold for changes in F1, the low-frequency formant (spectral peak) in the synthetic vowel sounds.

    6 months

  • F2 Discrimination Threshold

    Discrimination thresholds in % frequency for F2, the higher-frequency peak in synthetic vowel stimuli.

    6 month

Study Arms (3)

Normal Hearing

ACTIVE COMPARATOR

Signal processing to improve intelligibility

Other: Signal processing to improve intelligibility

Mild hearing loss

ACTIVE COMPARATOR

Signal processing to improve intelligibility

Other: Signal processing to improve intelligibility

Moderate hearing loss

ACTIVE COMPARATOR

Signal processing to improve intelligibility

Other: Signal processing to improve intelligibility

Interventions

Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.

Mild hearing lossModerate hearing lossNormal Hearing

Eligibility Criteria

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

You may qualify if:

  • Normal hearing, mild or moderate symmetric sensorineural hearing loss.

You may not qualify if:

  • Asymmetric hearing thresholds (more than 15 decibels (dB) threshold difference between the two ears at any frequency up to 4 kHz).
  • Severe hearing loss (greater than 60 dB hearing thresholds at any frequency up to 4 kHz).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Carney LH, Cameron DA, Kinast KB, Feld CE, Schwarz DM, Leong UC, McDonough JM. Effects of sensorineural hearing loss on formant-frequency discrimination: Measurements and models. Hear Res. 2023 Aug;435:108788. doi: 10.1016/j.heares.2023.108788. Epub 2023 May 8.

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Laurel H. Carney
Organization
University of Rochester

Study Officials

  • Laurel H Carney, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2018

First Posted

September 12, 2018

Study Start

June 9, 2020

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

May 29, 2025

Results First Posted

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations