DementiaNCT02729402
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
A study testing Cognitive Testing in people with Dementia and Hearing Loss, run by University of Utah.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Hearing Loss, Presbycusis
- What is being tested?
- Cognitive Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2015to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Those patients who are not able to undergo cochlear implantation surgery due to medical co-morbidities would not be eligible for the study.
About this study
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.
Read the 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
- Conditions
- Dementia, Hearing Loss, Presbycusis
- Being tested
- Cognitive Testing
- Keywords
- Adults
- Medical subject headings
- Dementia, Hearing Loss, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TestingOther
We will use a battery of neurocognitive tests to assess cognitive function before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Older Cochlear Implant Subjects | Experimental | We will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant. Receives: Other: Cognitive Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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."
Measured: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study start15 Jun 2015
- Primary completion6 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Gurgel, University of Utah
- Investigators
- Richard Gurgel, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02729402
- Sponsor's protocol ID
- 83983
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2015
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT02729402
- Acronym / sponsor ID
- 83983
- Conditions
- Dementia, Hearing Loss, Presbycusis
- Keywords
- Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Jun 2015 (actual)
- Primary completion
- 6 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 6 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Older Cochlear Implant Subjects | Experimental | Other: Cognitive TestingWe will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Those patients who are not able to undergo cochlear implantation surgery due to medical co-morbidities would not be eligible for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TestingWe will use a battery of neurocognitive tests to assess cognitive function before and after surgery | Other | Older Cochlear Implant Subjects |
Primary outcome
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.
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.
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.
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
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
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.
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.
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.
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.
1 secondary outcome
Mood and Psychosocial impact of cochlear implants on older adults
Time frame: Pre-operatively, at 6 months, 12 months, and five year post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gurgel, MD principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Testing in people with Dementia and Hearing Loss, run by University of Utah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Exam (MMSE) (time frame: Pre-operatively, at 6 months, 12 months, and five year post-operatively.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.