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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Hearing Loss; Presbycusis
• Intervention / Treatment: Other: Cognitive Testing

Detailed Description

Patients >65 year old who are cochlear implant candidates will be recruited for study participation. Candidacy criteria will be based on current FDA guidelines for cochlear implantation. After pre-operative cognitive testing, subjects will undergo cochlear implantation using standard operative techniques. Patient will have routine post-operative care and will follow up with audiology per standard post-activation routine - 1 week after activation, then monthly until a stable program is achieved. Hearing will be measured with standard audiometry to check for residual acoustic hearing, hearing in noise tests (HINT), aided thresholds, and consonant-nucleus-consonant (CNC) words at activation, 6 and 12 months, and 5 year post-operatively, and as often as needed in the interim to determine function.

Pre-operative and 6 and 12 month, and 5 year post-operative cognitive testing will be performed using a battery of tests that will differentiate verbal/auditory and non-verbal cognitive abilities.

Written informed consent will be sought from all individuals who will participate in the proposed project. Consent will be obtained by the principal investigator or key study personnel such as the research coordinator. When a potential participant has been identified, she/he will be visited in person. The participant will be given an overview of the study as well as written material that further explains the study and the responsibilities of the participant. Since some of our participants may have cognitive impairment, we will also make a determination about capacity to provide informed consent. Following presentation of the informed consent document, participants will be asked questions about the study (i.e. purpose, procedures, risks, and benefits). If these questions are adequately answered, then the participant will be judged to have capacity to provide informed consent. However, if these questions are not adequately answered, the participants will not be judged to have this capacity. In these latter cases, assent will be obtained from the participant and informed consent will be obtained from the participant's legally authorized representative (spouse, adult child

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Older Cochlear Implant Subjects; We will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant.	Other: Cognitive Testing; We will use a battery of neurocognitive tests to assess cognitive function before and after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood and Psychosocial impact of cochlear implants on older adults	Psychosocial well being was measured using the Geriatric Depression Scale (GDS), a 30-item questionnaire designed for rating depression for older adults. Scores considered "normal" range between 0-9. Scores 10-19 are considered "mild depression," and 20-30 suggest "severe depression."	Pre-operatively, at 6 months, 12 months, and five year post-operatively.

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Richard Gurgel, MD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2015
• Primary Completion (Actual): October 6, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimated): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Adults
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss, Sensorineural; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dementia; Hearing Loss; Presbycusis; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: 83983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO