Clinical trial NCT02729402: 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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Dementia
Hearing Loss
Presbycusis
Keywords: Adults
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
measure: What is impact on cognition of a cochlear implant in older adults
timeFrame: 4 years
Secondary outcomes:
measure: What is the psychosocial impact of cochlear implants on older adults
timeFrame: 4 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Richard Gurgel, MD
role: PRINCIPAL_INVESTIGATOR
References: