Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT06128161
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2023-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception
Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Organization:
Study Overview
Official Title:
Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception
Status:
COMPLETED
Status Verified Date:
2023-11
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:
An observational study to determine and assess perception of prosodic information in adults who use bimodal stimulation (cochlear implant plus hearing aid) when using both devices vs. cochlear implant alone.
Detailed Description:
People with severe to profound hearing loss often do not get satisfactory benefit from their hearing aids. A cochlear implant (CI) is a prosthetic device for the inner ear which can directly stimulate the auditory nerve, bypassing damaged inner ear hair cells and thus provide audible sensations to profoundly deaf patients.
Currently, one CI is funded by NHS England for adult patients and the eligibility criteria for implantation has been relaxed in recent years. As a result, there are now an increasing number of unilateral CI users who possess low-frequency residual hearing in their non-implanted ear. For many patients this residual hearing may still be usefully amplified by a HA. This configuration, consisting of a CI and a contralateral HA, is known as bimodal stimulation.
The PEPS-C receptive test battery has been previously used to assess prosody perception in hearing loss.
The current project will use selected tests from the PEPS-C prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and CI alone.
Currently, one CI is funded by NHS England for adult patients and the eligibility criteria for implantation has been relaxed in recent years. As a result, there are now an increasing number of unilateral CI users who possess low-frequency residual hearing in their non-implanted ear. For many patients this residual hearing may still be usefully amplified by a HA. This configuration, consisting of a CI and a contralateral HA, is known as bimodal stimulation.
The PEPS-C receptive test battery has been previously used to assess prosody perception in hearing loss.
The current project will use selected tests from the PEPS-C prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and CI alone.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: