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
About this trial
This is an interventional treatment trial for Hearing Loss
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
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
NCT ID
NCT04739436
First Posted
January 26, 2021
Last Updated
June 6, 2023
Sponsor
Duke University
Collaborators
Patient-Centered Outcomes Research Institute
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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