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Completed

NCT Number: NCT03402932

Administration Method of Cognitive Screening 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.

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Key information

Conditions

Hearing Loss, Sensorineural Cognition Disorders Cognitive Dysfunction Cognitive Impairment Ear Diseases Hearing Disorders Hearing Loss Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hearing Aid Laboratory

Evanston, Illinois, 60208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auditory amplified

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

Other

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

Auditory unamplified

Other

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

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 18, 2018
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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