NCT03402932

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2018

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 3, 2019

Completed
Last Updated

April 3, 2019

Status Verified

March 1, 2019

Enrollment Period

3 months

First QC Date

January 4, 2018

Results QC Date

August 22, 2018

Last Update Submit

March 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Auditory Working Memory Performance

    The outcome measure will be assessed immediately after the test.

Study Arms (4)

Auditory Amplified-Visual

EXPERIMENTAL

This arm is designed to test the contrast between auditory amplified and visual conditions.

Other: Auditory amplifiedOther: Visual

Auditory Amplified-Unamplified

EXPERIMENTAL

This arm is designed to test the contrast between auditory amplified and unamplified conditions.

Other: Auditory amplifiedOther: Auditory unamplified

Auditory Unamplified-Visual

EXPERIMENTAL

This arm is designed to test the contrast between auditory unamplified and visual conditions.

Other: VisualOther: Auditory unamplified

Younger control group

OTHER

This arm is designed to validate the visual version by comparing to the auditory version in a group of younger normal hearing controls.

Other: VisualOther: Auditory unamplified

Interventions

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.

Auditory Amplified-UnamplifiedAuditory Amplified-Visual
VisualOTHER

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

Auditory Amplified-VisualAuditory Unamplified-VisualYounger control group

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

Auditory Amplified-UnamplifiedAuditory Unamplified-VisualYounger control group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hearing Aid Laboratory

Evanston, Illinois, 60208, United States

Location

Related Publications (4)

  • 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.

    PMID: 27115241BACKGROUND
  • 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.

    PMID: 28559106BACKGROUND
  • 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.

    PMID: 23337978BACKGROUND
  • 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.

    PMID: 25325767BACKGROUND

MeSH Terms

Conditions

Hearing Loss, SensorineuralCognitive Dysfunction

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Jing Shen
Organization
Western Michigan University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 4, 2018

First Posted

January 18, 2018

Study Start

April 1, 2018

Primary Completion

July 10, 2018

Study Completion

July 10, 2018

Last Updated

April 3, 2019

Results First Posted

April 3, 2019

Record last verified: 2019-03

Locations