Trial Outcomes & Findings for Administration Method of Cognitive Screening in Older Individuals With Hearing Loss (NCT NCT03402932)
NCT ID: NCT03402932
Last Updated: 2019-04-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.
Results posted on
2019-04-03
Participant Flow
No significant event after andnrollment, prior to assignment
Participant milestones
| Measure |
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
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
13
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
Baseline characteristics by cohort
| Measure |
Group1: Younger Control (Auditory Unamplified - Visual)
n=13 Participants
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.
|
Group2: Auditory Amplified - Visual
n=8 Participants
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.
|
Group3: Auditory Amplified - Unamplified
n=8 Participants
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.
|
Group4: Auditory Unamplified - Visual
n=8 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Continuous
|
22.69 Years
STANDARD_DEVIATION 2.78 • n=5 Participants
|
77 Years
STANDARD_DEVIATION 5.91 • n=7 Participants
|
73.37 Years
STANDARD_DEVIATION 4.12 • n=5 Participants
|
73.75 Years
STANDARD_DEVIATION 6.35 • n=4 Participants
|
28.5 Years
STANDARD_DEVIATION 1.18 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
36 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group1: Auditory Unamplified -Visual (Younger Adults)
n=13 Participants
Younger adults with normal hearing group was included to validate the visual version of the test.
The auditory administration was unamplified. The visual administration had all test material visually presented.
|
Group2: Amplified-Visual (Older Adults w/ Hearing Loss)
n=8 Participants
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.
|
Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)
n=8 Participants
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.
|
Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)
n=8 Participants
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.
|
|---|---|---|---|---|
|
Cognitive Screening Results (Montreal Cognitive Assessment)
Condition 1
|
28.69 score on a scale
Standard Deviation 1.2
|
22.37 score on a scale
Standard Deviation 2.82
|
23.375 score on a scale
Standard Deviation 2.34
|
23 score on a scale
Standard Deviation 2.82
|
|
Cognitive Screening Results (Montreal Cognitive Assessment)
Condition 2
|
28.30 score on a scale
Standard Deviation 1.13
|
23.5 score on a scale
Standard Deviation 2.91
|
24.125 score on a scale
Standard Deviation 1.26
|
22.12 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Group1: Auditory Unamplified -Visual (Younger Adults)
n=13 Participants
Younger adults with normal hearing group was included to validate the visual version of the test.
The auditory administration was unamplified. The visual administration had all test material visually presented.
|
Group2: Amplified-Visual (Older Adults w/ Hearing Loss)
n=8 Participants
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.
|
Group3: Amplified-Unamplified (Older Adults w/ Hearing Loss)
n=8 Participants
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.
|
Group4: Visual-Unamplified (Older Adults w/ Hearing Loss)
n=8 Participants
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.
|
|---|---|---|---|---|
|
Auditory Working Memory Performance
Condition 1
|
82.88 percentage of correct recall
Standard Deviation 6.7
|
72.3 percentage of correct recall
Standard Deviation 7.1
|
69.1 percentage of correct recall
Standard Deviation 8.2
|
57.5 percentage of correct recall
Standard Deviation 11.5
|
|
Auditory Working Memory Performance
Condition 2
|
82.11 percentage of correct recall
Standard Deviation 7.6
|
66.9 percentage of correct recall
Standard Deviation 9.66
|
64.5 percentage of correct recall
Standard Deviation 11.4
|
61.3 percentage of correct recall
Standard Deviation 14.5
|
Adverse Events
Group1: Younger Auditory Unamplified - Visual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group2: Auditory Amplified - Visual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group3: Auditory Amplified - Unamplified
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group4: Auditory Unamplified - Visual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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