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Longitudinal Outcomes of Hearing Aids

Primary Purpose

Presbycusis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Over-the-counter fitting
Sponsored by
Yu-Hsiang Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Presbycusis focused on measuring Presbycusis, Hearing aid

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss

Exclusion Criteria:

  • Non-native speaker of English

Sites / Locations

  • University of IowaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OTC Group

Arm Description

In this group, the over-the-counter fitting will be used to provide hearing aids.

Outcomes

Primary Outcome Measures

Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using an ecological momentary assessment methodology. The name of the mobile device app is AudioSense2. The score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome.

Secondary Outcome Measures

Change of Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance / Profile of Hearing Aid Benefit (PHAP / PHAB)
The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance). The score difference between two PHAP (i.e., 6-week post intervention and 12-week post-intervention) is PHAB.
Change of Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 24 (more handicap).
Change of Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS)
The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).
Willingness-to-pay
Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study.
Change of Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).
Change of Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
Change of Speech recognition performance as measured by the Connected Speech Test (CST)
The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).
Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (paper-and-pencil administration)
The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using a paper-and-pencil format. he score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome.

Full Information

First Posted
July 19, 2019
Last Updated
May 11, 2023
Sponsor
Yu-Hsiang Wu
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT04030299
Brief Title
Longitudinal Outcomes of Hearing Aids
Official Title
Longitudinal Outcomes of Over-the-Counter Hearing Aids
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yu-Hsiang Wu
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
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery models to compensate for their impaired hearing. Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.
Detailed Description
Although hearing aids (HAs) are the first treatment of choice for age-related hearing loss, only 15-30% of those older Americans who could benefit, actually seek HAs out and use them. HA adoption rates are even lower for people with lower income and for racial and ethnic minorities. Although the answer to why so few older adults seek or use amplification is multidimensional, one common thread is that many people believe that HAs fitted using the audiologist-based model cost too much. Therefore, it is not surprising that there has been increased advocacy for a variety of over-the-counter (OTC) service-delivery models, which have increasingly been identified as important options for managing mild-to-moderate age-related hearing loss. Is the amplification intervention delivered using the OTC model an appropriate solution for age-related hearing loss? Although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The purpose of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months. Older adults with age-related hearing loss will be recruited. Pre-configured hearing aids (that simulate OTC hearing aids) will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. HA outcomes will be measured at 6-week and 12-week post intervention.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OTC Group
Arm Type
Experimental
Arm Description
In this group, the over-the-counter fitting will be used to provide hearing aids.
Intervention Type
Device
Intervention Name(s)
Over-the-counter fitting
Intervention Description
In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Primary Outcome Measure Information:
Title
Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
Description
The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using an ecological momentary assessment methodology. The name of the mobile device app is AudioSense2. The score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome.
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Secondary Outcome Measure Information:
Title
Change of Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance / Profile of Hearing Aid Benefit (PHAP / PHAB)
Description
The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance). The score difference between two PHAP (i.e., 6-week post intervention and 12-week post-intervention) is PHAB.
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Title
Change of Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
Description
The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 24 (more handicap).
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Title
Change of Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS)
Description
The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Title
Willingness-to-pay
Description
Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study.
Time Frame
12-week post intervention
Title
Change of Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Title
Change of Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
Description
The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Title
Change of Speech recognition performance as measured by the Connected Speech Test (CST)
Description
The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).
Time Frame
Change between 6-week post intervention and 12-week post-intervention
Title
Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (paper-and-pencil administration)
Description
The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The GHABP will be administered using a paper-and-pencil format. he score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome.
Time Frame
Change between 6-week post intervention and 12-week post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss Exclusion Criteria: Non-native speaker of English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Hsiang Wu, PhD
Phone
319-335-8728
Email
yu-hsiang-wu@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Stangl, AuD
Phone
319-338-9758
Email
lizabeth-stangl@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Wu, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Hsiang Wu, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The proposed research will include data from a total of 45 participants with hearing loss recruited State of Iowa and surrounding areas. The final dataset will include laboratory data (e.g., speech recognition score) and self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.
IPD Sharing Time Frame
The date will be available starting 6 months after publication of the main findings of the trial.
IPD Sharing Access Criteria
Even though the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of subjects with the survey data being collected. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technologies; and (3) a commitment to destroying or returning the data after analyses are completed.
Citations:
PubMed Identifier
20040828
Citation
Donahue A, Dubno JR, Beck L. Guest editorial: accessible and affordable hearing health care for adults with mild to moderate hearing loss. Ear Hear. 2010 Feb;31(1):2-6. doi: 10.1097/AUD.0b013e3181cbc783. No abstract available.
Results Reference
background
PubMed Identifier
21357188
Citation
Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing loss prevalence and risk factors among older adults in the United States. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):582-90. doi: 10.1093/gerona/glr002. Epub 2011 Feb 27.
Results Reference
background
PubMed Identifier
28252160
Citation
Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111. Erratum In: Am J Audiol. 2019 Sep 13;28(3):730.
Results Reference
background
PubMed Identifier
30458521
Citation
Brody L, Wu YH, Stangl E. A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Am J Audiol. 2018 Dec 6;27(4):581-593. doi: 10.1044/2018_AJA-18-0027.
Results Reference
background
PubMed Identifier
17580727
Citation
Takahashi G, Martinez CD, Beamer S, Bridges J, Noffsinger D, Sugiura K, Bratt GW, Williams DW. Subjective measures of hearing aid benefit and satisfaction in the NIDCD/VA follow-up study. J Am Acad Audiol. 2007 Apr;18(4):323-49. doi: 10.3766/jaaa.18.4.6.
Results Reference
background
PubMed Identifier
21514179
Citation
Gopinath B, Schneider J, Hartley D, Teber E, McMahon CM, Leeder SR, Mitchell P. Incidence and predictors of hearing aid use and ownership among older adults with hearing loss. Ann Epidemiol. 2011 Jul;21(7):497-506. doi: 10.1016/j.annepidem.2011.03.005. Epub 2011 Apr 21.
Results Reference
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Longitudinal Outcomes of Hearing Aids

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