Administration Method of Cognitive Screening in Older Individuals With Hearing Loss

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03402932
• Other study ID #: 2R01DC012289
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: July 10, 2018

Study information

• Verified date: March 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

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.
• Visual
The cognitive test will be administered visually by using timed computer slides.
• Auditory unamplified
The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.

Locations

Country	Name	City	State
United States	Hearing Aid Laboratory	Evanston	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Screening Results (Montreal Cognitive Assessment)	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	Auditory Working Memory Performance	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.