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Completed

NCT Number: NCT02729402

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive testing

Other

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

Primary outcomes

  1. Mini-mental State Exam (MMSE)

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

    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.

  2. Digit Span test (verbal)

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

    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.

  3. Stroop Color-Word Test (Golden version)

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

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

  4. Hopkins Verbal Learning Test-Revised (HVLT-R)

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

    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

  5. Hayling Sentence Completion Test

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

    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

  6. Spatial Span Test (visuospatial)

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

    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.

  7. d2 Test of Attention

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

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

  8. Brief Visuospatial Memory Test-Revised (BVMT-R)

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

    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.

  9. Trail Making Test Part B

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

    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.

Secondary outcomes

  1. Mood and Psychosocial impact of cochlear implants on older adults

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

    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."

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2016
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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