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Clinical Trials/NCT03402932
NCT03402932CompletedNot Applicable

The Impact of Test Administration Method on Cognitive Screening Results in Older Individuals With Hearing Loss

Northwestern University2 sites in 1 country37 target enrollmentStarted: April 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
37
Locations
2
Primary Endpoint
Cognitive Screening Results (Montreal Cognitive Assessment)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
60 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Auditory Amplified-Visual

Experimental

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

Intervention: Auditory amplified (Other)

Auditory Amplified-Visual

Experimental

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

Intervention: Visual (Other)

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.

Intervention: Auditory unamplified (Other)

Auditory Amplified-Unamplified

Experimental

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

Intervention: Auditory amplified (Other)

Auditory Amplified-Unamplified

Experimental

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

Intervention: Auditory unamplified (Other)

Auditory Unamplified-Visual

Experimental

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

Intervention: Visual (Other)

Auditory Unamplified-Visual

Experimental

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

Intervention: Auditory unamplified (Other)

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.

Intervention: Visual (Other)

Outcomes

Primary Outcomes

Cognitive Screening Results (Montreal Cognitive Assessment)

Time Frame: 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.

Secondary Outcomes

  • Auditory Working Memory Performance(The outcome measure will be assessed immediately after the test.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jing Shen

Research Assistant Professor

Northwestern University

Study Sites (2)

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