Trial Outcomes & Findings for Restoration of Spectral Resolution With Hearing-aid Amplification (NCT NCT03850678)
NCT ID: NCT03850678
Last Updated: 2025-01-14
Results Overview
Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit.
COMPLETED
NA
209 participants
Each test was approximately 10 minutes and was completed after each experimental manipulation
2025-01-14
Participant Flow
Participants completed a questionnaire about their medical and developmental history and educational level. Participants cognitive ability assessed using the Montreal Cognitive Assessment Basic (MOCA-B). Each subject underwent a routine audiological examination, including audiometric testing and tympanometry. Due to not qualifying on basis of inclusion or exclusion criteria (age, degree of hearing loss, or tympanometric findings), 85 participants were excluded before assignment to groups.
Participant milestones
| Measure |
Hearing Aid
Group of participants with hearing loss. Working memory span was assessed using the reading span test. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels, while manipulating different hearing aid parameters and also without the provision of amplification, was assessed.
Hearing Aid: Hearing Aid
|
Normal Hearing
Group of participants with normal hearing that serve as a reference group. Working memory span was assessed using the reading span test. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels was assessed.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
28
|
|
Overall Study
COMPLETED
|
85
|
25
|
|
Overall Study
NOT COMPLETED
|
11
|
3
|
Reasons for withdrawal
| Measure |
Hearing Aid
Group of participants with hearing loss. Working memory span was assessed using the reading span test. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels, while manipulating different hearing aid parameters and also without the provision of amplification, was assessed.
Hearing Aid: Hearing Aid
|
Normal Hearing
Group of participants with normal hearing that serve as a reference group. Working memory span was assessed using the reading span test. The ability of the subjects to detect different frequencies and to repeat speech presented at a variety of levels was assessed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Experimenter Error
|
1
|
1
|
|
Overall Study
Did Not Condition To Experiment
|
7
|
2
|
Baseline Characteristics
Restoration of Spectral Resolution With Hearing-aid Amplification
Baseline characteristics by cohort
| Measure |
Normal Hearing
n=25 Participants
Group of participants with normal hearing that serve as a reference group.
|
Hearing Aid
n=85 Participants
Group of participants with sensorineural hearing loss who were tested under conditions with hearing aid amplification.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
70 years
n=107 Participants
|
69 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=99 Participants
|
79 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
85 participants
n=107 Participants
|
110 participants
n=206 Participants
|
|
Montreal Cognitive Assessment Basic (MOCA-B)
|
26 scores on a scale
n=99 Participants
|
26 scores on a scale
n=107 Participants
|
26 scores on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Each test was approximately 10 minutes and was completed after each experimental manipulationPopulation: Consisted of varying conditions and number of participants per condition, including three different compression speeds (instant, fast, slow), three different number of compression channels (4, 8, 16) and two different amplification conditions (unaided, aided).
Measure of spectral resolution (Q10) obtained from the fast psychophysical tuning curve test. For this study, Q10 was computed as the target frequency divided by the bandwidth of the tuning curve (10 dB above the threshold at the tip of the tuning curve test). Higher numbers on this scale indicate sharper (better) tuning. The lower limit for this scale is 0 and there is no upper limit.
Outcome measures
| Measure |
Hearing Aid Group
n=68 Participants
Participants with hearing loss who were tested with hearing aid amplification.
|
Normal Hearing
n=14 Participants
Comparison group of individuals with normal hearing. This group was only tested without hearing aid amplification (in the unaided condition).
|
|---|---|---|
|
Spectral Resolution
Slow
|
3.2 units on a scale
Standard Deviation 1.6
|
—
|
|
Spectral Resolution
Instant
|
3.5 units on a scale
Standard Deviation 2.2
|
—
|
|
Spectral Resolution
Fast
|
3.3 units on a scale
Standard Deviation 1.9
|
—
|
|
Spectral Resolution
4 Channels
|
2.8 units on a scale
Standard Deviation 1.2
|
—
|
|
Spectral Resolution
8 Channels
|
2.5 units on a scale
Standard Deviation 1.7
|
—
|
|
Spectral Resolution
16 Channels
|
3.5 units on a scale
Standard Deviation 1.1
|
—
|
|
Spectral Resolution
Unaided
|
2.7 units on a scale
Standard Deviation 1.7
|
3.9 units on a scale
Standard Deviation 2.0
|
|
Spectral Resolution
Aided
|
3.2 units on a scale
Standard Deviation 1.1
|
—
|
PRIMARY outcome
Timeframe: Each test was approximately 10 minutes and was completed after each experimental manipulationPopulation: Participants with normal hearing were only tested unaided. Participants with hearing loss were tested unaided, 4 channels with fast compression, and 16 channels with fast compression. Fast compression with 4 and 16 channels were assessed to assess the potential role of changes in spectral resolution to changes in speech recognition between these two conditions.
measure of spatial release from masking (dB) for a masker presented at 70 dB SPL.
Outcome measures
| Measure |
Hearing Aid Group
n=17 Participants
Participants with hearing loss who were tested with hearing aid amplification.
|
Normal Hearing
n=15 Participants
Comparison group of individuals with normal hearing. This group was only tested without hearing aid amplification (in the unaided condition).
|
|---|---|---|
|
Speech Recognition
unaided
|
6.6 dB
Standard Deviation 5.1
|
4.5 dB
Standard Deviation 1.9
|
|
Speech Recognition
4 channels
|
—
|
4.0 dB
Standard Deviation 3.2
|
|
Speech Recognition
16 channels
|
—
|
3.7 dB
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Each test was approximately 30 minutes and was completed only once per subject.Measure of working memory (correctly repeated words from the reading span test). The minimum (poorer) and maximum (better) values are 0 and 57, respectively.
Outcome measures
| Measure |
Hearing Aid Group
n=14 Participants
Participants with hearing loss who were tested with hearing aid amplification.
|
Normal Hearing
n=42 Participants
Comparison group of individuals with normal hearing. This group was only tested without hearing aid amplification (in the unaided condition).
|
|---|---|---|
|
Working Memory
|
23.6 score on a scale
Standard Deviation 6.8
|
20.1 score on a scale
Standard Deviation 7.4
|
Adverse Events
Hearing Aid
Normal Hearing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place