Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

Not Applicable

Completed

• Conditions: Cognitive Impairment; Hearing Loss, Sensorineural
• Interventions: Other: Auditory amplified; Other: Visual; Other: Auditory unamplified

• Registration Number: NCT03402932
• Lead Sponsor: Northwestern University

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 Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-18
• Study Start: 2018-04-01
• Primary Completion: 2018-07-10
• Study Completion: 2018-07-10
• Results First Submitted: 2018-08-22
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-11
• Last Update Submitted: 2019-03-11
• Results First Posted: 2019-04-03
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Have sensorineural hearing loss
• Have normal or corrected-to-normal vision

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Exclusion Criteria

• Have conductive hearing loss;
• Have history of otologic or neurologic disorders
• Have dementia
• Non-native speakers of English

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Auditory Amplified-Visual	Auditory amplified	This arm is designed to test the contrast between auditory amplified and visual conditions.
Younger control group	Visual	This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.
Auditory Amplified-Unamplified	Auditory unamplified	This arm is designed to test the contrast between auditory amplified and unamplified conditions.
Auditory Unamplified-Visual	Visual	This arm is designed to test the contrast between auditory unamplified and visual conditions.
Auditory Amplified-Visual	Visual	This arm is designed to test the contrast between auditory amplified and visual conditions.
Auditory Unamplified-Visual	Auditory unamplified	This arm is designed to test the contrast between auditory unamplified and visual conditions.
Auditory Amplified-Unamplified	Auditory amplified	This arm is designed to test the contrast between auditory amplified and unamplified conditions.
Younger control group	Auditory unamplified	This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.

Primary Outcome Measures

Name	Time	Method
Cognitive Screening Results (Montreal Cognitive Assessment)	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 Outcome Measures

Name	Time	Method
Auditory Working Memory Performance	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.

Trial Locations

Locations (1)

Hearing Aid Laboratory; 🇺🇸 Evanston, Illinois, United States