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Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Primary Purpose

Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing amplification
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

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

Inclusion Criteria:

  • 50+ years of age
  • Ability to read and understand English
  • Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of <55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold <80 in each ear), based on a hearing test obtained within the last 6 months by a licensed audiologist.
  • Symmetrical hearing loss defined by <20 dB difference between the pure-tone average of 500, 1000, and 2000 Hz between ears)
  • Interested in purchasing hearing aids, but is open minded about trying one or two hearing aids
  • No prior hearing aid use longer than 3 months (as documented via self-report)
  • Adequate literacy to complete questionnaires
  • Willing to purchase study-specific hearing aid(s)
  • Access to a smart phone and the internet

Exclusion Criteria:

  • Concerns for middle ear pathology (e.g., air bone gap of >15 dB at 2 consecutive octave frequencies in either ear)
  • Concerns for retrocochlear pathology by audiologist (e.g unilateral tinnitus or ear fullness, referral to ENT/Auditory Brainstem Response testing to r/o acoustic neuroma)
  • Severe tinnitus as the reason for seeking amplification
  • Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology)
  • History of fluctuating hearing loss

Sites / Locations

  • Duke University Medical CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Bilateral hearing aid fitting group

Unilateral hearing aid fitting group

Arm Description

Outcomes

Primary Outcome Measures

Change in Hearing Aid Benefit
Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)

Secondary Outcome Measures

Change in Hearing Aid Benefit
Measured by Ecological Momentary Assessment (EMA) with in-situ Glasgow Hearing Aid Benefit Profile (GHABP)
Change in Hearing Aid Benefit as measured by speech in noise performance
Bamford -Kowal-Bench speech in noise (BKB SIN) test
Change in Hearing Aid Benefit as measured by Auditory Working Memory
Abbreviated Word Auditory Recognition and Recall Measure (WARRM)
Change in Hearing Aid Satisfaction
Measured by Satisfaction with Amplification in Daily Life (SADL) survey completion
Hours of Hearing Aid Use
Measured by automated data log extracted from hearing aid
Hours of Hearing Aid Use
Measured by automated data log extracted from hearing aid
Change in Hearing Related Quality Life
Measured by Hearing Handicap Inventory for Elderly (HHIE) survey completion
Change in complex ecological listening
Measured by Speech Spatial Qualities (SSQ) survey completion
Hearing aid expectations
Measured by Expected Consequences of Hearing Aid Ownership (ECHO) survey completion
Change in global hearing aid outcomes
Measured by International Outcome Inventory for Hearing aids (IOI_HA) survey completion
Experience with hearing aid assignment
Measured by a self-reported questionnaire using a 10 point scale (1 = not at all and 10 is very highly likely/full recommendation)
Experience with hearing aid assignment
Measured by open ended questions and discussion during a participant focus group
Number of participants in each arm that chose 0 hearing aids as measured by patient preference
Measured by participant's final choice of 0, 1, or 2 hearing aids
Number of participants in each arm that chose 1 hearing aid as measured by patient preference
Measured by participant's final choice of 0, 1, or 2 hearing aids
Number of participants in each arm that chose 2 hearing aids as measured by patient preference
Measured by participant's final choice of 0, 1, or 2 hearing aids
Preference with hearing aid assignment
Measured by open ended questions and discussion during a participant focus group
Change in Hearing Aid Benefit
Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)

Full Information

First Posted
January 26, 2021
Last Updated
June 6, 2023
Sponsor
Duke University
Collaborators
Patient-Centered Outcomes Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04739436
Brief Title
Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
Official Title
Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Patient-Centered Outcomes Research Institute

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
This study aims to evaluate the benefit of bilateral hearing aid use compared to a unilateral hearing aid. Patients with mild to moderate bilateral hearing loss who are considering the purchase of a commercially available hearing aid will be considered for participation. Eligible participants will be randomized to one of the following treatment arms: (1) a bilateral hearing aid fitting group, and (2) a unilateral hearing aid fitting group.
Detailed Description
Primary objectives: To compare the hearing-aid benefit of unilateral versus bilateral fittings of commercially-available hearing aids that incorporate a dome coupling (open or closed dome as required by degree of hearing loss, or custom coupling if clinically indicated), which represents the most popular style used for mild to moderate hearing loss. To compare other multi-dimensional outcomes including hearing-related quality of life, hearing aid satisfaction in patient-nominated goals, ecological hearing aid outcomes, and hearing aid use. Secondary objectives: To compare performance outcomes for unilateral versus bilateral hearing aid fittings To explore the differences in long-term patient reported outcomes for their final hearing aid configuration choice To explore patient experiences in each group (unilateral vs bilateral), and patient preference in regards to their choice of final hearing aid configuration. This study is being conducted at Duke and Vanderbilt Medical Centers, with Duke functioning as the main coordinating center. Study participants will pay out of pocket for the hearing aid(s), but will be able to extend the hearing aid fitting trial period from 60 days (standard of care) to 180 days (6 months). Participants will be given the opportunity to change their hearing aid configuration and/or return their hearing aid(s) for a refund after 3 months, and again at the end of the 6 month study period.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bilateral hearing aid fitting group
Arm Type
Other
Arm Title
Unilateral hearing aid fitting group
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hearing amplification
Intervention Description
Bilateral vs. unilateral hearing aids for hearing loss
Primary Outcome Measure Information:
Title
Change in Hearing Aid Benefit
Description
Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in Hearing Aid Benefit
Description
Measured by Ecological Momentary Assessment (EMA) with in-situ Glasgow Hearing Aid Benefit Profile (GHABP)
Time Frame
3 months, 6 months
Title
Change in Hearing Aid Benefit as measured by speech in noise performance
Description
Bamford -Kowal-Bench speech in noise (BKB SIN) test
Time Frame
Baseline, 3 months
Title
Change in Hearing Aid Benefit as measured by Auditory Working Memory
Description
Abbreviated Word Auditory Recognition and Recall Measure (WARRM)
Time Frame
Baseline, 3 months
Title
Change in Hearing Aid Satisfaction
Description
Measured by Satisfaction with Amplification in Daily Life (SADL) survey completion
Time Frame
3 months , 6 months
Title
Hours of Hearing Aid Use
Description
Measured by automated data log extracted from hearing aid
Time Frame
1 month
Title
Hours of Hearing Aid Use
Description
Measured by automated data log extracted from hearing aid
Time Frame
3 months
Title
Change in Hearing Related Quality Life
Description
Measured by Hearing Handicap Inventory for Elderly (HHIE) survey completion
Time Frame
Baseline, 3 months, 6 months
Title
Change in complex ecological listening
Description
Measured by Speech Spatial Qualities (SSQ) survey completion
Time Frame
Baseline, 3 months, 6 months
Title
Hearing aid expectations
Description
Measured by Expected Consequences of Hearing Aid Ownership (ECHO) survey completion
Time Frame
Baseline
Title
Change in global hearing aid outcomes
Description
Measured by International Outcome Inventory for Hearing aids (IOI_HA) survey completion
Time Frame
3 months, 6 months
Title
Experience with hearing aid assignment
Description
Measured by a self-reported questionnaire using a 10 point scale (1 = not at all and 10 is very highly likely/full recommendation)
Time Frame
3 months
Title
Experience with hearing aid assignment
Description
Measured by open ended questions and discussion during a participant focus group
Time Frame
3 months
Title
Number of participants in each arm that chose 0 hearing aids as measured by patient preference
Description
Measured by participant's final choice of 0, 1, or 2 hearing aids
Time Frame
3 months
Title
Number of participants in each arm that chose 1 hearing aid as measured by patient preference
Description
Measured by participant's final choice of 0, 1, or 2 hearing aids
Time Frame
3 months
Title
Number of participants in each arm that chose 2 hearing aids as measured by patient preference
Description
Measured by participant's final choice of 0, 1, or 2 hearing aids
Time Frame
3 months
Title
Preference with hearing aid assignment
Description
Measured by open ended questions and discussion during a participant focus group
Time Frame
3 months
Title
Change in Hearing Aid Benefit
Description
Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time Frame
Baseline, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50+ years of age Ability to read and understand English Mild to moderate sensorineural hearing loss (defined by a pure-tone average at 500, 1000, and 2000 Hz of <55 dB HL in each ear, and the 3000 Hz and 4000 Hz threshold <80 in each ear), based on a hearing test obtained within the last 6 months by a licensed audiologist. Symmetrical hearing loss defined by <20 dB difference between the pure-tone average of 500, 1000, and 2000 Hz between ears) Interested in purchasing hearing aids, but is open minded about trying one or two hearing aids No prior hearing aid use longer than 3 months (as documented via self-report) Adequate literacy to complete questionnaires Willing to purchase study-specific hearing aid(s) Access to a smart phone and the internet Exclusion Criteria: Concerns for middle ear pathology (e.g., air bone gap of >15 dB at 2 consecutive octave frequencies in either ear) Concerns for retrocochlear pathology by audiologist (e.g unilateral tinnitus or ear fullness, referral to ENT/Auditory Brainstem Response testing to r/o acoustic neuroma) Severe tinnitus as the reason for seeking amplification Co-morbid condition that would interfere with study (e.g., dementia, blindness, neurologic pathology) History of fluctuating hearing loss
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Walker
Phone
919-684-1732
Email
amy.walker1@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Barvina Toledo
Phone
919-684-3888
Email
bt124@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherri Smith, AuD,PhD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherri Smith, AuD,PhD
Phone
919-613-1110
Email
sherri.smith@duke.edu
First Name & Middle Initial & Last Name & Degree
Amy Walker
Phone
919-684-1732
Email
amy.walker1@duke.edu
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Ricketts, PhD
Email
todd.a.ricketts@vumc.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Open access to de-identified, coded IPD will be made available via Duke's Research Data Repository.

Learn more about this trial

Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

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