An interventional study of Auditory amplified and Visual in Hearing Loss, Sensorineural and Cognitive Impairment, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 60 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by Northwestern University · Not applicable, Interventional, and Screening
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.
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.
Exclusion Criteria:
This arm is designed to test the contrast between auditory amplified and visual conditions.
Other: Auditory amplified · Other: Visual
This arm is designed to test the contrast between auditory amplified and unamplified conditions.
Other: Auditory amplified · Other: Auditory unamplified
This arm is designed to test the contrast between auditory unamplified and visual conditions.
Other: Visual · Other: Auditory unamplified
This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.
Other: Visual · Other: Auditory unamplified
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.
The cognitive test will be administered visually by using timed computer slides.
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
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.
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.
| Milestone | Group1: Auditory -Visual (Younger Adults w/ Normal Hearing) | Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) |
|---|---|---|---|---|
| Started | 13 | 8 | 8 | 8 |
| Completed | 13 | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| score on a scale | Group1: Auditory Unamplified -Visual (Younger Adults) | Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) |
|---|---|---|---|---|
| Condition 1 | 28.69 ± 1.2 | 22.37 ± 2.82 | 23.375 ± 2.34 | 23 ± 2.82 |
| Condition 2 | 28.30 ± 1.13 | 23.5 ± 2.91 | 24.125 ± 1.26 | 22.12 ± 2.8 |
Older individuals were presented with lists of words and instructed to repeat them back. After each word list, they had to recall the words.
| percentage of correct recall | Group1: Younger Control (Auditory Unamplified - Visual) | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual |
|---|---|---|---|---|
| Condition 1 | 82.88 ± 6.7 | 72.3 ± 7.1 | 69.1 ± 8.2 | 57.5 ± 11.5 |
| Condition 2 | 82.11 ± 7.6 | 66.9 ± 9.66 | 64.5 ± 11.4 | 61.3 ± 14.5 |
Collected over The outcome measures are behavioral measures (e.g., cognitive screening test scores) and were collected within a short period of time (2 hours).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group1: Younger Auditory Unamplified - Visual | — | — | — |
| Group2: Auditory Amplified - Visual | — | — | — |
| Group3: Auditory Amplified - Unamplified | — | — | — |
| Group4: Auditory Unamplified - Visual | — | — | — |
| Age, Categorical(Participants) | Group1: Younger Control (Auditory Unamplified - Visual) | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 13 | 0 | 0 | 0 | 13 |
| >=65 years | 0 | 8 | 8 | 8 | 24 |
| Age, Continuous(Years) | Group1: Younger Control (Auditory Unamplified - Visual) | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual | Total |
|---|---|---|---|---|---|
| Mean | 22.69 ± 2.78 | 77 ± 5.91 | 73.37 ± 4.12 | 73.75 ± 6.35 | 28.5 ± 1.18 |
| Sex: Female, Male(Participants) | Group1: Younger Control (Auditory Unamplified - Visual) | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual | Total |
|---|---|---|---|---|---|
| Female | 10 | 4 | 5 | 5 | 24 |
| Male | 3 | 4 | 3 | 3 | 13 |
| Race (NIH/OMB)(Participants) | Group1: Younger Control (Auditory Unamplified - Visual) | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 12 | 8 | 8 | 8 | 36 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Group1: Younger Control (Auditory Unamplified - Visual) | Group2: Auditory Amplified - Visual | Group3: Auditory Amplified - Unamplified | Group4: Auditory Unamplified - Visual | Total |
|---|---|---|---|---|---|
| United States | 13 | 8 | 8 | 8 | 36 |
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Plan to share: Undecided — The results will be shared in the form of presentations and publications. Study protocol is available upon request.
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Northwestern University