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Restoration of Spectral Resolution With Hearing-aid Amplification

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing Aid
Sponsored by
University of Nebraska Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • cognitive impairment

Sites / Locations

  • Barkley Memorial CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hearing Aid

Normal Hearing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Spectral resolution
Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test
Speech Recognition
measure of percent correctly repeated words embedded in sentences and background noise

Secondary Outcome Measures

Working memory
Measure of working memory (correctly repeated words and sentences from the reading span test)

Full Information

First Posted
February 18, 2019
Last Updated
October 13, 2023
Sponsor
University of Nebraska Lincoln
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03850678
Brief Title
Restoration of Spectral Resolution With Hearing-aid Amplification
Official Title
Restoration of Spectral Resolution With Hearing-aid Amplification
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska Lincoln
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Adults with hearing loss are more vulnerable to interference from background noise than adults with normal hearing. Despite the fact that the ability to extract speech information imbedded in background noise requires decoding differences in level across frequency (spectral information), few studies have addressed the extent to which spectral information can be provided to listeners with hearing loss. This fundamental gap in our knowledge prevents society from effectively addressing the systemic effects of hearing loss on communication, income, and ability to socialize with others. This work is a new application of established methods of characterizing spectral resolution to that of the most common device for rehabilitation of hearing loss, hearing-aid amplification. Because hearing aids do not require premarket approval, FDA oversight is not applicable to this clinical trial. The experiments will examine the degree to which access to spectral information can be restored to adults with hearing loss and the feasibility of utilizing this information to decrease interference from background noise. Aim 1 will delineate the impact of hearing-aid amplification on spectral decoding. Technology options that must be set by the clinician or hearing-aid manufacturer will be examined, including the frequency-specific gain, compressor speed, and number of compression channels. The proposed experiments will test the hypothesis that restoration of the lost dynamic range of hearing can support the encoding of spectral information. It is also hypothesized that the combination of technology options that best restore access to spectral information will differ across individuals and that these differences across individuals can be partially accounted for by an estimate of outer hair cell function. Aim 2 will determine the extent to which restoring access to spectral information supports speech recognition in background noise, under the guiding hypothesis that improving spectral resolution increases speech understanding. If it can be demonstrated that measures of spectral resolution with the provision of amplification are useful at delineating those who stand to benefit from different technology options, the knowledge gained could then be applied to the clinic to allow for clinicians to more successfully choose among different rehabilitation options.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid
Arm Type
Experimental
Arm Description
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.
Arm Title
Normal Hearing
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing Aid
Intervention Description
Hearing Aid
Primary Outcome Measure Information:
Title
Spectral resolution
Description
Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test
Time Frame
Each test is approximately 10 minutes and will be completed after each experimental manipulation
Title
Speech Recognition
Description
measure of percent correctly repeated words embedded in sentences and background noise
Time Frame
Each test is approximately 10 minutes and will be completed after each experimental manipulation
Secondary Outcome Measure Information:
Title
Working memory
Description
Measure of working memory (correctly repeated words and sentences from the reading span test)
Time Frame
Each test is approximately 30 minutes and will be completed once per subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Brennan, PhD
Phone
4024723132
Email
amplab@unl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Brennan, PhD
Organizational Affiliation
University of Nebraska Lincoln
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barkley Memorial Center
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68583
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Brennan, PhD
Phone
402-472-3079
Email
marc.brennan@unl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Restoration of Spectral Resolution With Hearing-aid Amplification

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