Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-26 @ 12:36 AM
Study NCT ID:
NCT02729402
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-27
First Post:
2015-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: