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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04357704
Other study ID # PIC_10
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2019
Est. completion date September 1, 2019

Study information

Verified date November 2018
Source Oticon Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Other:
S0N0
(no ITD)
S0N500
(ITD +500µs on noise)
S-500N500
(ITD -500µs on signal and +500 µs on noise)
S0N1000
(ITD + 1000 µs on noise)
S0Nuncorr
(no ITD cue, with uncorrelated stimulation frame)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Oticon Medical

Outcome

Type Measure Description Time frame Safety issue
Primary 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 speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears. day 0
Secondary ITD sensitivity in bilateral cochlear implant user 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. day 0
Secondary Preferred jitter in bilateral cochlear implant user 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. day 0
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