Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT02729402 |
| Other study ID # |
83983 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2015 |
| Est. completion date |
November 2025 |
Study information
| Verified date |
September 2023 |
| Source |
University of Utah |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
