Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

NCT ID: NCT03402932

Last Updated: 2019-04-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-07-10

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Sensorineural Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Auditory Amplified-Visual

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

Group Type EXPERIMENTAL

Auditory amplified

Intervention Type 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.

Visual

Intervention Type OTHER

The cognitive test will be administered visually by using timed computer slides.

Auditory Amplified-Unamplified

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

Group Type EXPERIMENTAL

Auditory amplified

Intervention Type 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.

Auditory unamplified

Intervention Type OTHER

The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.

Auditory Unamplified-Visual

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

Group Type EXPERIMENTAL

Visual

Intervention Type OTHER

The cognitive test will be administered visually by using timed computer slides.

Auditory unamplified

Intervention Type OTHER

The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.

Younger control group

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

Group Type OTHER

Visual

Intervention Type OTHER

The cognitive test will be administered visually by using timed computer slides.

Auditory unamplified

Intervention Type OTHER

The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.

Interventions

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Auditory 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.

Intervention Type OTHER

Visual

The cognitive test will be administered visually by using timed computer slides.

Intervention Type OTHER

Auditory unamplified

The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Jing Shen

Research Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hearing Aid Laboratory

Evanston, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27115241 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28559106 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23337978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25325767 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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2R01DC012289

Identifier Type: NIH

Identifier Source: org_study_id

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