NCT03850678

Brief Summary

The objective of this study protocol is to determine the efficacy of using aided measures of spectral resolution to set the dynamic range of hearing with hearing-aid amplification. Measures of spectral resolution will be obtained, as will measures of speech recognition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

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

February 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 2, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

4.7 years

First QC Date

February 18, 2019

Results QC Date

November 19, 2024

Last Update Submit

January 10, 2025

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

  • Spectral Resolution

    Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit.

    Each test was approximately 10 minutes and was completed after each experimental manipulation

  • Speech Recognition

    measure of spatial release from masking (dB) for a masker presented at 70 dB SPL.

    Each test was approximately 10 minutes and was completed after each experimental manipulation

Secondary Outcomes (1)

  • Working Memory

    Each test was approximately 30 minutes and was completed only once per subject.

Study Arms (2)

Hearing Aid

EXPERIMENTAL

Group of participants with hearing loss. Subjects will complete a questionnaire that asks relevant questions about their medical and developmental history and educational level. Participants will be screened for a potential cognitive impairment using the Montreal Cognitive Assessment Basic (MOCA-B). Working memory span will be assessed using the reading span test. Each subject will undergo a routine audiological examination, including audiometric testing and tympanometry. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels, while manipulating different hearing aid parameters and also without the provision of amplification, will be assessed.

Device: Hearing Aid

Normal Hearing

NO INTERVENTION

Group of participants with normal hearing that serve as a reference group. Subjects will complete a questionnaire that asks relevant questions about their medical and developmental history and educational level. Participants will be screened for a potential cognitive impairment using the Montreal Cognitive Assessment Basic (MOCA-B). Working memory span will be assessed using the reading span test. Each subject will undergo a routine audiological examination, including audiometric testing and tympanometry. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels will be assessed.

Interventions

Hearing AidDEVICE

Hearing Aid

Hearing Aid

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal tympanograms (peak admittance of ≥ 0.2 mmhos, -200 to 50); Hearing thresholds for normal hearing group less than or equal to 20 decibels in hearing level (dB HL) from .25 to 8 kHz. Pure-tone average (2, 4 \& 6 kHz) hearing thresholds for participants with hearing loss of 30 - 65 dB HL.

You may not qualify if:

  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barkley Memorial Center

Lincoln, Nebraska, 68583, United States

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Hearing Aids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Results Point of Contact

Title
Marc Brennan
Organization
University of Nebraska-Lincoln
marc.brennan@unl.edu
4024723132

Study Officials

  • Marc Brennan, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 22, 2019

Study Start

April 2, 2019

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

January 14, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)