Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception
1 other identifier
observational
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2023
CompletedFirst Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedNovember 13, 2023
November 1, 2023
7 months
September 6, 2023
November 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
PEPS-C speech test battery
Test battery of 7 speech tests examining prosodic elements of speech, each section scored out of 16 (112 in total higher scores better outcome)
Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions
Secondary Outcomes (4)
AB words speech test
Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions
SSQ12 Questionnaire
Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions
Unaided Soundfield Audiometry
Tested at one time point at day 1 of study after recruitment
BKB sentences speech test
Tested at one time point at day 1 of study after recruitment in both Cochlear Implant Alone and Cochlear Implant and Hearing Aid Together conditions
Interventions
Contralateral Hearing Aid to Cochlear Implant
Eligibility Criteria
Patients at St. Thomas' Hearing Implant Centre
You may qualify if:
- Adult
- Has unilateral Cochlear Implant
- Consistent use of Hearing Aid
- Obtains some benefit in speech discrimination from hearing aid (\> 20% AB words)
- Post-lingually deafened
- Fluent English
You may not qualify if:
- Longstanding significant asymmetry (\> 20 dB HL 4 frequency average) in hearing where the unimplanted ear is the worse ear
- Inconsistent Hearing Aid use
- Significant conductive hearing loss (\> 20 dB HL 4 frequency average)
- Using Electro-Acoustic stimulation Cochlear Implant
- Aetiology of hearing loss likely associated with auditory neuropathy
- Significantly abnormal appearance of cochlea or cochlear nerve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's and St. Thomas' NHS Foundation Trust
London, SE1 7EH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2023
First Posted
November 13, 2023
Study Start
August 30, 2022
Primary Completion
March 23, 2023
Study Completion
March 23, 2023
Last Updated
November 13, 2023
Record last verified: 2023-11