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

September 30, 2023 updated by: Richard Gurgel, University of Utah

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 years
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 years
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.
4 years
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.
4 years
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.
4 years
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.
4 years
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).
4 years
What is impact on cognition of a cochlear implant in older adults
Time Frame: 4 years
We will measure cognitive function by administering the Hayling Sentence Completion test.
4 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: Richard Gurgel, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

March 30, 2016

First Posted (Estimated)

April 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83983

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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