Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Cochlear Hearing Loss Clinical Trial

Official title:

Comparison of Unilateral CI vs. Bimodal Stimulation in Prosodic Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06128161
• Other study ID #: 307417
• Status: Completed
• Start date: August 30, 2022
• Est. completion date: March 23, 2023

Study information

• Verified date: November 2023
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Device:
• Hearing Aid
Contralateral Hearing Aid to Cochlear Implant

Locations

Country	Name	City	State
United Kingdom	Guy's and St. Thomas' NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AB words speech test	Word speech discrimination test in quiet, 30 words presented, scored as % correct, higher score 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	SSQ12 Questionnaire	Speech Spatial Qualities patient reported outcome measure, scored out of 120 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	Unaided Soundfield Audiometry	Soundfield hearing test without Cochlear Implant or Hearing Aid	Tested at one time point at day 1 of study after recruitment
Secondary	BKB sentences speech test	Sentences speech discrimination test in quiet, 100 words presented, 50 male, 50 female voice, scored as %	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