Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
Primary Purpose
Dementia, Hearing Loss, Presbycusis
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Dementia focused on measuring Adults
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Older Cochlear Implant Subjects
Arm Description
We will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant.
Outcomes
Primary Outcome Measures
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the mini-mental status exam (MMSE).
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the D2 test.
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the Hopkins Verbal Learning Test (HVLT) test.
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the Digit Span vs. Spatial Span test.
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the Hayling Sentence Completion test.
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the Stroop Color Word test.
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the Brief Visuospatial Memory test.
What is impact on cognition of a cochlear implant in older adults
We will measure cognitive function by administering the Trails A/B test.
Secondary Outcome Measures
What is the psychosocial impact of cochlear implants on older adults
We will measure psychosocial well being (i.e. depression and social interaction) by using the Geriatric depression scale on psychosocial status will be administered
Full Information
NCT ID
NCT02729402
First Posted
November 4, 2015
Last Updated
September 30, 2023
Sponsor
University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT02729402
Brief Title
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
Official Title
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 2015 (undefined)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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 post-operatively, and as often as needed in the interim to determine function.
Pre-operative and 6 and 12 month 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Hearing Loss, Presbycusis
Keywords
Adults
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Older Cochlear Implant Subjects
Arm Type
Experimental
Arm Description
We will assign the study participants to a diagnostic intervention (cognitive testing) before and after their cochlear implant.
Intervention Type
Other
Intervention Name(s)
Cognitive Testing
Intervention Description
We will use a battery of neurocognitive tests to assess cognitive function before and after surgery
Primary Outcome Measure Information:
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the mini-mental status exam (MMSE).
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the D2 test.
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the Hopkins Verbal Learning Test (HVLT) test.
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the Digit Span vs. Spatial Span test.
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the Hayling Sentence Completion test.
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the Stroop Color Word test.
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the Brief Visuospatial Memory test.
Time Frame
4 years
Title
What is impact on cognition of a cochlear implant in older adults
Description
We will measure cognitive function by administering the Trails A/B test.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
What is the psychosocial impact of cochlear implants on older adults
Description
We will measure psychosocial well being (i.e. depression and social interaction) by using the Geriatric depression scale on psychosocial status will be administered
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gurgel, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
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