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Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

Primary Purpose

Hearing Loss, Sensorineural, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Auditory amplified
Visual
Auditory unamplified
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hearing Loss, Sensorineural

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hearing Aid Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Other

Arm Label

Auditory Amplified-Visual

Auditory Amplified-Unamplified

Auditory Unamplified-Visual

Younger control group

Arm Description

This arm is designed to test the contrast between auditory amplified and visual conditions.

This arm is designed to test the contrast between auditory amplified and unamplified conditions.

This arm is designed to test the contrast between auditory unamplified and visual conditions.

This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 4, 2018
Last Updated
March 11, 2019
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03402932
Brief Title
Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
Official Title
The Impact of Test Administration Method on Cognitive Screening Results in Older Individuals With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Cognitive Impairment

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auditory Amplified-Visual
Arm Type
Experimental
Arm Description
This arm is designed to test the contrast between auditory amplified and visual conditions.
Arm Title
Auditory Amplified-Unamplified
Arm Type
Experimental
Arm Description
This arm is designed to test the contrast between auditory amplified and unamplified conditions.
Arm Title
Auditory Unamplified-Visual
Arm Type
Experimental
Arm Description
This arm is designed to test the contrast between auditory unamplified and visual conditions.
Arm Title
Younger control group
Arm Type
Other
Arm Description
This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.
Intervention Type
Other
Intervention Name(s)
Auditory amplified
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Visual
Intervention Description
The cognitive test will be administered visually by using timed computer slides.
Intervention Type
Other
Intervention Name(s)
Auditory unamplified
Intervention Description
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
Primary Outcome Measure Information:
Title
Cognitive Screening Results (Montreal Cognitive Assessment)
Description
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.
Secondary Outcome Measure Information:
Title
Auditory Working Memory Performance
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Hearing Aid Laboratory
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The results will be shared in the form of presentations and publications. Study protocol is available upon request.
Citations:
PubMed Identifier
27115241
Citation
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.
Results Reference
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PubMed Identifier
28559106
Citation
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.
Results Reference
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PubMed Identifier
23337978
Citation
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.
Results Reference
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PubMed Identifier
25325767
Citation
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.
Results Reference
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Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

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