An interventional study of Cognitive Testing in Dementia, Hearing Loss and Presbycusis, sponsored by University of Utah. Completed. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of Utah · Not applicable, Interventional, and Diagnostic
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.
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
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's enrollment of 37 is below the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →University of Utah is the lead sponsor of 994 studies on the registry; 175 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 69 (61%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
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."
Time frame: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2015 to primary completion in Oct 2025, 123 months.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 123 months is above that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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