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Variability In Hearing Aid Outcomes In Older Adults

Primary Purpose

Hearing Loss, Presbycusis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing Aid Fitting A
Hearing Aid Fitting B
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hearing Loss focused on measuring hearing aid

Eligibility Criteria

54 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL
  • Non hearing aided wearer within the previous year
  • Participants will be in good health (self-report)
  • Normal or corrected to normal vision(≤20/50)

Exclusion Criteria:

  • Conductive, or asymmetric hearing loss
  • Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss)
  • Hearing loss remediated with a cochlear implant (cannot wear hearing aids)
  • Significant history of otologic or neurologic disorders
  • Non English speaking participants
  • Score of 23 or below on Mini-Mental Status Exam (MMSE)
  • Score of 22 or below on Montreal Cognitive Assessment (MoCA)
  • Any clinically significant unstable or progressive medical condition
  • Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study.
  • Participants will be divided into low and high working groups based upon the results of their Lunner working memory reading span test. Once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.

Sites / Locations

  • University of Colorado at Boulder

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hearing Aid Fitting Order A

Hearing Aid Fitting Order B

Arm Description

High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.

Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.

Outcomes

Primary Outcome Measures

Speech Intelligibility Score
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.

Secondary Outcome Measures

Effectiveness of Aural Rehabilitation (EAR)
The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
Adherence
Average number of hours per day the hearing aid was worn.

Full Information

First Posted
May 15, 2015
Last Updated
October 23, 2020
Sponsor
Northwestern University
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT02448706
Brief Title
Variability In Hearing Aid Outcomes In Older Adults
Official Title
Characterizing Variability in Hearing Aid Outcomes Among Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this project is to find out if the way a hearing aid processes a sound signal should be determined in part by an individual's cognitive characteristics. We anticipate that the outcome of this work will be a battery of assessments that will guide hearing aid processing for older patients with hearing loss.
Detailed Description
Response to hearing aids is highly variable, with some individuals reporting much more benefit than others. Preliminary work by our laboratory and others suggests that patient factors-including cognition-may contribute to differences in how individuals respond to altered speech cues, such as those alterations introduced by hearing aid processing. The long-term goal of this work is to improve hearing aid outcomes by optimizing hearing aid processing for each individual.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Presbycusis
Keywords
hearing aid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hearing Aid Fitting Order A
Arm Type
Active Comparator
Arm Description
High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Arm Title
Hearing Aid Fitting Order B
Arm Type
Active Comparator
Arm Description
Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks.
Intervention Type
Device
Intervention Name(s)
Hearing Aid Fitting A
Other Intervention Name(s)
Hearing Aid
Intervention Type
Device
Intervention Name(s)
Hearing Aid Fitting B
Primary Outcome Measure Information:
Title
Speech Intelligibility Score
Description
Participants listen to sentences in a background of noise and repeat the sentence heard. The outcome is percentage of correctly repeated words.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Effectiveness of Aural Rehabilitation (EAR)
Description
The listener rates the extent to which hearing has improved with the hearing aid (0=least improved, 100=most improved).
Time Frame
6 weeks
Title
Speech and Spatial Qualities of Hearing (SSQ) Questionnaire
Description
Listener rates her/his perceived ability. Each question describes a different situation, such as listening to one talker in quiet. Test is scored from 0 to 10, with 10 = best score.
Time Frame
6 weeks
Title
Adherence
Description
Average number of hours per day the hearing aid was worn.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sensorineural Hearing loss with pure-tone thresholds 25-70 dB HL at octave frequencies between 250 and 4000 Hz, 4 frequency PTA of ≥ 30 dB HL Non hearing aided wearer within the previous year Participants will be in good health (self-report) Normal or corrected to normal vision(≤20/50) Exclusion Criteria: Conductive, or asymmetric hearing loss Hearing loss exceeding the limits that can be successfully aided with hearing aids (i.e., profound hearing loss) Hearing loss remediated with a cochlear implant (cannot wear hearing aids) Significant history of otologic or neurologic disorders Non English speaking participants Score of 23 or below on Mini-Mental Status Exam (MMSE) Score of 22 or below on Montreal Cognitive Assessment (MoCA) Any clinically significant unstable or progressive medical condition Any condition which, in the opinion of the investigator, places the participant at unacceptable risk if he or she were to participate in the study. Participants will be divided into low and high working groups based upon the results of their Lunner working memory reading span test. Once either high or low working memory group is filled (approximately 25 participants) we will selectively enroll participants to fill the other category.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela E Souza, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn H Arehart, PhD
Organizational Affiliation
University of Colorado at Boulder
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30052097
Citation
Anderson M, Rallapalli V, Schoof T, Souza P, Arehart K. The use of self-report measures to examine changes in perception in response to fittings using different signal processing parameters. Int J Audiol. 2018 Nov;57(11):809-815. doi: 10.1080/14992027.2018.1490035. Epub 2018 Jul 27.
Results Reference
derived

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Variability In Hearing Aid Outcomes In Older Adults

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