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

NCT ID: NCT04357704

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-09-01

Brief Summary

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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.

Detailed Description

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

Conditions

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Hearing Loss, Cochlear

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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bilateral cochlear implant recipients

Group Type EXPERIMENTAL

S0N0

Intervention Type OTHER

(no ITD)

S0N500

Intervention Type OTHER

(ITD +500µs on noise)

S-500N500

Intervention Type OTHER

(ITD -500µs on signal and +500 µs on noise)

S0N1000

Intervention Type OTHER

(ITD + 1000 µs on noise)

S0Nuncorr

Intervention Type OTHER

(no ITD cue, with uncorrelated stimulation frame)

normal hearing listners

Group Type ACTIVE_COMPARATOR

S0N0

Intervention Type OTHER

(no ITD)

S0N500

Intervention Type OTHER

(ITD +500µs on noise)

S-500N500

Intervention Type OTHER

(ITD -500µs on signal and +500 µs on noise)

S0N1000

Intervention Type OTHER

(ITD + 1000 µs on noise)

S0Nuncorr

Intervention Type OTHER

(no ITD cue, with uncorrelated stimulation frame)

Interventions

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S0N0

(no ITD)

Intervention Type OTHER

S0N500

(ITD +500µs on noise)

Intervention Type OTHER

S-500N500

(ITD -500µs on signal and +500 µs on noise)

Intervention Type OTHER

S0N1000

(ITD + 1000 µs on noise)

Intervention Type OTHER

S0Nuncorr

(no ITD cue, with uncorrelated stimulation frame)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas Guevara, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital University Nice-IUFC

Alexis Bozorg-Grayeli, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital University Dijon-François Mitterrand

Related Links

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http://www.oticonmedical.com

oticon medical website

Other Identifiers

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PIC_10

Identifier Type: -

Identifier Source: org_study_id

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