Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults

NCT02729402 | Completed DMC

• 1 other identifier: 83983
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

The subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for standard-of-care cochlear implant. Cognitive tests will be administered preoperative, and postoperative at 6 and 12 month, and 5 year intervals.

Conditions

Dementia; Hearing Loss; Presbycusis

Keywords

Adults

Outcome Measures

Primary Outcomes (9)

• Mini-mental State Exam (MMSE)

  Mini-Mental State Examination (MMSE) measures global cognitive function. Score ranges from 0-30; a score of 0 indicates severe cognitive impairment and a score of 30 indicates no cognitive impairment. Higher scores indicate better outcome.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively.

• Digit Span test (verbal)

  Measures simple attention. In the first part, subjects are required to recall and recite digits in forward sequence (0-16 points), the second part requires subjects to recall and recite digits in backward sequence (0-14 points). Higher scores indicate better outcome.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively.

• Stroop Color-Word Test (Golden version)

  Stroop Color-Word Test measures sustained attention. Raw score is the number of answers correct out of 100. Higher scores = better outcome.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively.

• Hopkins Verbal Learning Test-Revised (HVLT-R)

  Measures verbal learning and memory. Score ranges from 0-36; a score of 0 indicates no words recalled and a score of 36 indicates perfect recall. Higher scores indicate better outcome

  Pre-operatively, at 6 months, 12 months, and five year post-operatively

• Hayling Sentence Completion Test

  Measures executive functioning. Overall scaled score ranges from 1-10; a score of 1 indicates impaired function and 10 indicates very superior function. Higher score indicates better outcome

  Pre-operatively, at 6 months, 12 months, and five year post-operatively

• Spatial Span Test (visuospatial)

  Assesses attention, short-term and working memory. Two parts, the first part requires subjects to physically point at the digits shown to them in forward sequence (0-16 points), the second part requires subjects to point the digits in backward sequence (0-16 points). Higher scores indicate better outcome.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively

• d2 Test of Attention

  Assesses sustained and selective attention. The score is calculated as: Total Number of Items minus Errors. Higher scores indicate better outcome.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively

• Brief Visuospatial Memory Test-Revised (BVMT-R)

  Measures visuospatial learning and memory First Section assess immediate recall where raw scores range from 0-36; a score of 0 indicates no figures recalled and a score of 36 indicates perfect recall. Second Section assess delayed recall ( 25-minute delay) with a score range from 0-12. A higher score indicates better recall outcome.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively.

• Trail Making Test Part B

  Executive functioning is scored by the total time in seconds required to complete the task. The time to complete each task is recorded as a score. A higher score indicates poor performance and less time indicates better performance.

  Pre-operatively, at 6 months, 12 months, and five year post-operatively.

Secondary Outcomes (1)

• Mood and Psychosocial impact of cochlear implants on older adults

  Pre-operatively, at 6 months, 12 months, and five year post-operatively.

Study Arms (1)

Older Cochlear Implant Subjects

EXPERIMENTAL

We will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant.

Other: Cognitive Testing

Interventions

Cognitive Testing OTHER

We will use a battery of neurocognitive tests to assess cognitive function before and after surgery

Older Cochlear Implant Subjects

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• The subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for a cochlear implant.

You may not qualify if:

• Those patients who are not able to undergo cochlear implantation surgery due to medical co-morbidities would not be eligible for the study.

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Dementia; Hearing Loss; Presbycusis

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hearing Loss, Sensorineural

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Richard Gurgel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants underwent diagnostic assessments of cognition and mood before cochlear implant (CI) implantation and 6 and 12 months after implantation. All participants were subsequently invited to complete an additional follow-up assessment five years post-implantation. A subgroup of participants (n=16) completed assessments five years post-implantation.

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: April 6, 2016
• Study Start: June 15, 2015
• Primary Completion: October 6, 2025
• Study Completion: October 10, 2025
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share