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

Hearing Loss, Cochlear Clinical Trial

— APPIC  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04357704
• Other study ID #: PIC_10
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

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

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

External Links

•   oticon medical website