Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auditory Amplified-Visual | Experimental | This arm is designed to test the contrast between auditory amplified and visual conditions. |
|
| Auditory Amplified-Unamplified | Experimental | This arm is designed to test the contrast between auditory amplified and unamplified conditions. |
|
| Auditory Unamplified-Visual | Experimental | This arm is designed to test the contrast between auditory unamplified and visual conditions. |
|
| Younger control group | Other | This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auditory amplified | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The outcome measure will be assessed immediately after the test. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hearing Aid Laboratory | Evanston | Illinois | 60208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27115241 | Background | Jorgensen LE, Palmer CV, Pratt S, Erickson KI, Moncrieff D. The Effect of Decreased Audibility on MMSE Performance: A Measure Commonly Used for Diagnosing Dementia. J Am Acad Audiol. 2016 Apr;27(4):311-23. doi: 10.3766/jaaa.15006. | |
| 28559106 | Background | Guerreiro MJS, Van Gerven PWM. Disregarding hearing loss leads to overestimation of age-related cognitive decline. Neurobiol Aging. 2017 Aug;56:180-189. doi: 10.1016/j.neurobiolaging.2017.05.001. Epub 2017 May 10. |
Not provided
Not provided
The results will be shared in the form of presentations and publications. Study protocol is available upon request.
Not provided
Not provided
Not provided
Not provided
No significant event after andnrollment, prior to assignment
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group1: Auditory -Visual (Younger Adults w/ Normal Hearing) | A group of younger adults with normal hearing is included to validate the visual version of the tests |
| FG001 | Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | 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. |
| FG002 | Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | 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. |
| FG003 | Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms. |
|
The outcome measures are behavioral measures (e.g., cognitive screening test scores) and were collected within a short period of time (2 hours).
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group1: Younger Auditory Unamplified - Visual | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jing Shen | Western Michigan University | 2693878067 | jing.shen@wmich.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2018 | Nov 26, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 1, 2019 | Feb 7, 2019 | Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Visual | Other | The cognitive test will be administered visually by using timed computer slides. |
|
| Auditory unamplified | Other | The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level. |
|
| 23337978 | Background | Lin FR, Yaffe K, Xia J, Xue QL, Harris TB, Purchase-Helzner E, Satterfield S, Ayonayon HN, Ferrucci L, Simonsick EM; Health ABC Study Group. Hearing loss and cognitive decline in older adults. JAMA Intern Med. 2013 Feb 25;173(4):293-9. doi: 10.1001/jamainternmed.2013.1868. |
| 25325767 | Background | Dupuis K, Pichora-Fuller MK, Chasteen AL, Marchuk V, Singh G, Smith SL. Effects of hearing and vision impairments on the Montreal Cognitive Assessment. Neuropsychol Dev Cogn B Aging Neuropsychol Cogn. 2015;22(4):413-37. doi: 10.1080/13825585.2014.968084. Epub 2014 Oct 17. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Group2: Amplified-Visual (Older Adults w/ Hearing Loss) | 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 administration presented all test material visually. |
| OG002 | Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss) | Auditory amplified: The cognitive test was administered by using customized amplification. Auditory unamplified: The cognitive test was administered by using a generic presentation level that simulates a normal conversational level. |
| OG003 | Group4: Visual-Unamplified (Older Adults w/ Hearing Loss) | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of correct recall | The outcome measure will be assessed immediately after the test. |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group2: Auditory Amplified - Visual | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Group3: Auditory Amplified - Unamplified | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Group4: Auditory Unamplified - Visual | All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| Condition 2 |
|