Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

March 11, 2019 updated by: Jing Shen, Northwestern University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Hearing Aid Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Auditory Amplified-Visual
This arm is designed to test the contrast between auditory amplified and visual conditions.
Other: 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.
Other: Visual
The cognitive test will be administered visually by using timed computer slides.
Experimental: Auditory Amplified-Unamplified
This arm is designed to test the contrast between auditory amplified and unamplified conditions.
Other: 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.
Other: Auditory unamplified
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
Experimental: Auditory Unamplified-Visual
This arm is designed to test the contrast between auditory unamplified and visual conditions.
Other: Visual
The cognitive test will be administered visually by using timed computer slides.
Other: Auditory unamplified
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
Other: 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.
Other: Visual
The cognitive test will be administered visually by using timed computer slides.
Other: Auditory unamplified
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory Working Memory Performance
Time Frame: 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.
The outcome measure will be assessed immediately after the test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

July 10, 2018

Study Completion (Actual)

July 10, 2018

Study Registration Dates

First Submitted

January 4, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (Actual)

January 18, 2018

Study Record Updates

Last Update Posted (Actual)

April 3, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R01DC012289 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The results will be shared in the form of presentations and publications. Study protocol is available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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