Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User

Not Applicable

Withdrawn

• Conditions: Hearing Loss, Cochlear
• Interventions: Other: S0N0; Other: S0N500; Other: S-500N500; Other: S0N1000; Other: S0Nuncorr

• Registration Number: NCT04357704
• Lead Sponsor: Oticon Medical

Brief Summary

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patient with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

Detailed Description

Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization

Bilateral cochlear implants certainly restore a part of binaurality

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-27
• Study Start: 2019-04-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-09-01
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Fluent in local language
• Normal hearing listener:
• pure tone threshold > 25dB from 125Hz to 12kHz
• Cochlear implant recipient
• bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
• Digisonic SP® cochlear implants user

Exclusion Criteria

• binaural sensitivity threshold < 1000µs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal hearing listners	S0N1000	-
bilateral cochlear implant recipients	S0N1000	-
normal hearing listners	S0N0	-
normal hearing listners	S-500N500	-
bilateral cochlear implant recipients	S0N0	-
bilateral cochlear implant recipients	S0Nuncorr	-
normal hearing listners	S0N500	-
normal hearing listners	S0Nuncorr	-
bilateral cochlear implant recipients	S0N500	-
bilateral cochlear implant recipients	S-500N500	-

Primary Outcome Measures

Name	Time	Method
speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue	day 0	SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.

Secondary Outcome Measures

Name	Time	Method
Preferred jitter in bilateral cochlear implant user	day 0	Speech signal and noise are presented at 65dB SPL. Participant adjust the jitter of the train pulse timing from 0 to +1000µs to improve the Interaural Time Difference.
speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners	day 0	SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.
ITD sensitivity in bilateral cochlear implant user	day 0	Speech signal and noise are presented at 65dB SPL. Participant adjust the Interaural Time Difference between the speech signal and noise between -1000 and +1000µs. Participant moves the cursor on the interface until he/she hear a difference in sound.