Cognitive Impairment, Hearing Loss, Sensorineural
Conditions
Brief summary
The objectives of the current project aim to determine whether a more controlled amplification method or a visual administration has an effect on hearing impaired older individuals' cognitive test scores.
Detailed description
Aim 1 is to create a visually administered condition of a cognitive test and to validate this condition in comparison to the auditory administration. Data will be collected from younger individuals with normal hearing. Each younger individual is tested using both visual and auditory condition and the scores are compared across the two conditions. It is anticipated that the scores will not be significantly different between the two conditions. Aim 2 is to examine the test condition effect on cognitive testing results in older individuals with hearing loss. The three test conditions include auditory unamplified, auditory amplified, and visual. Each older individual will be tested using two different test conditions. It is predicted the auditory amplified and visual administrations will alleviate the cognitive load associated with hearing difficulty and lead to improved performance on the test.
Interventions
OTHERVisual
The cognitive test will be administered visually by using timed computer slides.
OTHERAuditory unamplified
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
OTHERAuditory amplified
The cognitive test will be administered using a computer-based signal processing to amplify the instruction. The presentation level is customized to the individual's hearing thresholds.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Have sensorineural hearing loss * Have normal or corrected-to-normal vision
Exclusion criteria
* Have conductive hearing loss; * Have history of otologic or neurologic disorders * Have dementia * Non-native speakers of English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Screening Results (Montreal Cognitive Assessment) | The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms. | The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table). MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Auditory Working Memory Performance | The outcome measure will be assessed immediately after the test. | Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words. |
Countries
United States
Participant flow
Pre-assignment details
No significant event after andnrollment, prior to assignment
Participants by arm
| Arm | Count |
|---|---|
| Group1: Younger Control (Auditory Unamplified - Visual) This arm is for validating the visual version of the tests with younger individuals with normal hearing.
Visual: The cognitive test was administered visually by using timed computer slides.
Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level. | 13 |
| Group2: Auditory Amplified - Visual Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.
Visual: The cognitive test was administered visually by using timed computer slides. | 8 |
| Group3: Auditory Amplified - Unamplified Auditory amplified: The cognitive test was administered using a computer-based signal processing to amplify the instruction. The presentation level was customized to the individual's hearing thresholds.
Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level. | 8 |
| Group4: Auditory Unamplified - Visual Visual: The cognitive test was administered visually by using timed computer slides.
Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level. | 8 |
| Total | 37 |
Baseline characteristics
| Characteristic | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual | Group1: Younger Control (Auditory Unamplified - Visual) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 8 Participants | 8 Participants | 0 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 13 Participants | 13 Participants |
| Age, Continuous | 77 Years STANDARD_DEVIATION 5.91 | 73.37 Years STANDARD_DEVIATION 4.12 | 73.75 Years STANDARD_DEVIATION 6.35 | 22.69 Years STANDARD_DEVIATION 2.78 | 28.5 Years STANDARD_DEVIATION 1.18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 8 Participants | 12 Participants | 36 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants | 13 participants | 36 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 5 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Cognitive Screening Results (Montreal Cognitive Assessment)
The cognitive screening test of Montreal Cognitive Assessment (MoCA) was administered to 4 groups with different administration method conditions (see arms/groups table). MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure of this study and this score ranges from 0-30, with higher score being better performance.
Time frame: The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group1: Auditory Unamplified -Visual (Younger Adults) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 1 | 28.69 score on a scale | Standard Deviation 1.2 |
| Group1: Auditory Unamplified -Visual (Younger Adults) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 2 | 28.30 score on a scale | Standard Deviation 1.13 |
| Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 2 | 23.5 score on a scale | Standard Deviation 2.91 |
| Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 1 | 22.37 score on a scale | Standard Deviation 2.82 |
| Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 1 | 23.375 score on a scale | Standard Deviation 2.34 |
| Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 2 | 24.125 score on a scale | Standard Deviation 1.26 |
| Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 1 | 23 score on a scale | Standard Deviation 2.82 |
| Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) | Cognitive Screening Results (Montreal Cognitive Assessment) | Condition 2 | 22.12 score on a scale | Standard Deviation 2.8 |
Secondary
Auditory Working Memory Performance
Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.
Time frame: The outcome measure will be assessed immediately after the test.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group1: Auditory Unamplified -Visual (Younger Adults) | Auditory Working Memory Performance | Condition 1 | 82.88 percentage of correct recall | Standard Deviation 6.7 |
| Group1: Auditory Unamplified -Visual (Younger Adults) | Auditory Working Memory Performance | Condition 2 | 82.11 percentage of correct recall | Standard Deviation 7.6 |
| Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | Auditory Working Memory Performance | Condition 2 | 66.9 percentage of correct recall | Standard Deviation 9.66 |
| Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | Auditory Working Memory Performance | Condition 1 | 72.3 percentage of correct recall | Standard Deviation 7.1 |
| Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Auditory Working Memory Performance | Condition 1 | 69.1 percentage of correct recall | Standard Deviation 8.2 |
| Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Auditory Working Memory Performance | Condition 2 | 64.5 percentage of correct recall | Standard Deviation 11.4 |
| Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) | Auditory Working Memory Performance | Condition 1 | 57.5 percentage of correct recall | Standard Deviation 11.5 |
| Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) | Auditory Working Memory Performance | Condition 2 | 61.3 percentage of correct recall | Standard Deviation 14.5 |