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Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults

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ClinicalTrials.gov Identifier: NCT02729402
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2016
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Richard Gurgel, University of Utah

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.


Condition or disease Intervention/treatment Phase
Dementia Hearing Loss Presbycusis Other: Cognitive Testing Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
Study Start Date : November 2015
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Older Cochlear Implant Subjects
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




Primary Outcome Measures :
  1. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the mini-mental status exam MMSE.

  2. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the D2 test.

  3. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the Hopkins Verbal Learning Test (HVLT) test.

  4. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the Digit Span vs. Spatial Span test.

  5. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 yeras ]
    We will measure cognitive function by administering the Hayling Sentence Completion test.

  6. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the Stroop Color Word test.

  7. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the Brief Visuospatial Memory test.

  8. What is impact on cognition of a cochlear implant in older adults [ Time Frame: 4 years ]
    We will measure cognitive function by administering the Trails A/B test.


Secondary Outcome Measures :
  1. What is the psychosocial impact of cochlear implants on older adults [ Time Frame: 4 years ]
    We will measure pyschosocial well being (i.e. depression and social interaction) by using the Geriatric depression scale on psychosocial status will be administered



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729402


Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Richard Gurgel, MD University of Utah
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Responsible Party: Richard Gurgel, MD, University of Utah
ClinicalTrials.gov Identifier: NCT02729402    
Other Study ID Numbers: 83983
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Richard Gurgel, University of Utah:
Adults
Additional relevant MeSH terms:
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Hearing Loss
Presbycusis
Nervous System Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Hearing Loss, Sensorineural