Brief Summary

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients 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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Apr 2019

Shorter than P25 for not_applicable

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

November 27, 2018

Completed

4 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed

8 months until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed

Last Updated

August 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

November 27, 2018

Last Update Submit

July 30, 2025

Conditions

Hearing Loss, Cochlear

Keywords

Iteraural Time Difference

Outcome Measures

Primary Outcomes (1)

speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue
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.
day 0

Secondary Outcomes (3)

speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners
day 0
ITD sensitivity in bilateral cochlear implant user
day 0
Preferred jitter in bilateral cochlear implant user
day 0

Study Arms (2)

bilateral cochlear implant recipients

EXPERIMENTAL

Other: S0N0Other: S0N500Other: S-500N500Other: S0N1000Other: S0Nuncorr

normal hearing listners

ACTIVE COMPARATOR

Other: S0N0Other: S0N500Other: S-500N500Other: S0N1000Other: S0Nuncorr