Hearing Loss, Presbycusis
Conditions
Keywords
hearing aid
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.
Interventions
DEVICEHearing Aid Fitting A
DEVICEHearing Aid Fitting B
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
54 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants received the same baseline measures, regardless of the hearing aid fitting order to which they were randomized | 47 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 72 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Reading span task | 34 percentage of correctly recalled words |
| Region of Enrollment United States | 47 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 0 / 49 | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Level of Signal Manipulation | Speech Intelligibility Score | 69 percentage of correct responses | Standard Deviation 18 |
| Low Level of Signal Manipulation | Speech Intelligibility Score | 78 percentage of correct responses | Standard Deviation 15 |
Secondary
Adherence
Average number of hours per day the hearing aid was worn.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Level of Signal Manipulation | Adherence | 9 hours per day | Standard Deviation 3.7 |
| Low Level of Signal Manipulation | Adherence | 9 hours per day | Standard Deviation 3.4 |
Secondary
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).
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Level of Signal Manipulation | Effectiveness of Aural Rehabilitation (EAR) | 60.0 score on a scale | Standard Deviation 23.3 |
| Low Level of Signal Manipulation | Effectiveness of Aural Rehabilitation (EAR) | 74.2 score on a scale | Standard Deviation 21 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Level of Signal Manipulation | Speech and Spatial Qualities of Hearing (SSQ) Questionnaire | 6.47 score on a scale | Standard Deviation 1.4 |
| Low Level of Signal Manipulation | Speech and Spatial Qualities of Hearing (SSQ) Questionnaire | 6.95 score on a scale | Standard Deviation 1.1 |