Variability In Hearing Aid Outcomes In Older Adults
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Hearing Aid Fitting Order A High level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. |
Device: Hearing Aid Fitting A
Other Names:
Device: Hearing Aid Fitting B
|
| Active Comparator: Hearing Aid Fitting Order B Low level of signal manipulation for 6 weeks, followed by a low level of signal manipulation for 6 weeks. |
Device: Hearing Aid Fitting A
Other Names:
Device: Hearing Aid Fitting B
|
Outcome Measures
Primary Outcome Measures
- Speech Intelligibility Score [6 weeks]
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) [6 weeks]
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 [6 weeks]
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 [6 weeks]
Average number of hours per day the hearing aid was worn.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Colorado at Boulder | Boulder | Colorado | United States | 80309 |
Sponsors and Collaborators
- Northwestern University
- National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
- Principal Investigator: Pamela E Souza, PhD, Northwestern University
- Principal Investigator: Kathryn H Arehart, PhD, University of Colorado at Boulder
Study Documents (Full-Text)
More Information
Publications
None provided.- 1R01DC012289-01
- 1R01DC012289-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Hearing Aid Fitting Order A | Hearing Aid Fitting Order B |
|---|---|---|
| Arm/Group Description | High level of signal manipulation (5 weeks), then low level of signal manipulation (5 weeks) | Low level of signal manipulation (5 weeks), then high level of signal manipulation (5 weeks) |
| Period Title: Overall Study | ||
| STARTED | 25 | 24 |
| Withdrew for Personal Reasons | 1 | 1 |
| Completed Baseline Testing | 24 | 23 |
| COMPLETED | 20 | 20 |
| NOT COMPLETED | 5 | 4 |
Baseline Characteristics
| Arm/Group Title | All Study Participants |
|---|---|
| Arm/Group Description | All study participants received the same baseline measures, regardless of the hearing aid fitting order to which they were randomized |
| Overall Participants | 47 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
9
19.1%
|
| >=65 years |
38
80.9%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
72
|
| Sex: Female, Male (Count of Participants) | |
| Female |
24
51.1%
|
| Male |
23
48.9%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
47
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
47
100%
|
| Reading span task (percentage of correctly recalled words) [Mean (Full Range) ] | |
| Mean (Full Range) [percentage of correctly recalled words] |
34
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | High Level of Signal Manipulation | Low Level of Signal Manipulation |
|---|---|---|
| Arm/Group Description | Fit with hearing aids set to a high level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial. | Fit with hearing aids set to a low level of signal manipulation (6 weeks). Half of the participants completed this condition in the first 6 weeks of the trial, and half in the second 6 weeks of the trial. |
| Measure Participants | 40 | 40 |
| Mean (Standard Deviation) [percentage of correct responses] |
69
(18)
|
78
(15)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hearing Aid Fitting A | Hearing Aid Fitting B |
|---|---|---|
| Arm/Group Description | High level of signal manipulation Hearing Aid Fitting A | Low level of signal manipulation Hearing Aid Fitting B |
| Measure Participants | 40 | 40 |
| Mean (Standard Deviation) [score on a scale] |
60.0
(23.3)
|
74.2
(21.0)
|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hearing Aid Fitting A | Hearing Aid Fitting B |
|---|---|---|
| Arm/Group Description | High level of signal manipulation Hearing Aid Fitting A | Low level of signal manipulation Hearing Aid Fitting B |
| Measure Participants | 40 | 40 |
| Mean (Standard Deviation) [score on a scale] |
6.47
(1.4)
|
6.95
(1.1)
|
| Title | Adherence |
|---|---|
| Description | Average number of hours per day the hearing aid was worn. |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Hearing Aid Fitting A | Hearing Aid Fitting B |
|---|---|---|
| Arm/Group Description | High level of signal manipulation Hearing Aid Fitting A | Low level of signal manipulation Hearing Aid Fitting B |
| Measure Participants | 40 | 40 |
| Mean (Standard Deviation) [hours per day] |
9
(3.7)
|
9
(3.4)
|
Adverse Events
| Time Frame | 12 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Hearing Aid Fitting A | Hearing Aid Fitting B | ||
| Arm/Group Description | High level of signal manipulation | Low level of signal manipulation | ||
All Cause Mortality |
||||
| Hearing Aid Fitting A | Hearing Aid Fitting B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/49 (0%) | ||
Serious Adverse Events |
||||
| Hearing Aid Fitting A | Hearing Aid Fitting B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/49 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Hearing Aid Fitting A | Hearing Aid Fitting B | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/49 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Pamela Souza |
|---|---|
| Organization | Northwestern University |
| Phone | 8474912433 |
| p-souza@northwestern.edu |
- 1R01DC012289-01
- 1R01DC012289-01