Clinical trial NCT03402932: Administration Method of Cognitive Screening in Older Individuals With Hearing Loss
Official title: The Impact of Test Administration Method on Cognitive Screening Results in Older Individuals With Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Cognitive Impairment
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 37
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Screening Results (Montreal Cognitive Assessment)
timeFrame: The outcome measure was assessed immediately after the test. This applies to both conditions for all the arms.
Secondary outcomes:
measure: Auditory Working Memory Performance
timeFrame: The outcome measure will be assessed immediately after the test.
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Hearing Aid Laboratory
state: Illinois
Study officials:
References:
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.
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.
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.
citation: 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.