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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
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dementia focused on measuring Adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    November 4, 2015
    Last Updated
    September 30, 2023
    Sponsor
    University of Utah
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    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

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