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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hearing Loss, Cochlear
• Intervention / Treatment: Other: S0N0; Other: S0N500; Other: S-500N500; Other: S0N1000; Other: S0Nuncorr

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: bilateral cochlear implant recipients	Other: S0N0; (no ITD); Other: S0N500; (ITD +500µs on noise); Other: S-500N500; (ITD -500µs on signal and +500 µs on noise); Other: S0N1000; (ITD + 1000 µs on noise); Other: S0Nuncorr; (no ITD cue, with uncorrelated stimulation frame)
Active Comparator: normal hearing listners	Other: S0N0; (no ITD); Other: S0N500; (ITD +500µs on noise); Other: S-500N500; (ITD -500µs on signal and +500 µs on noise); Other: S0N1000; (ITD + 1000 µs on noise); Other: S0Nuncorr; (no ITD cue, with uncorrelated stimulation frame)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Oticon Medical
• Investigators: Principal Investigator: Nicolas Guevara, MD, Hospital University Nice-IUFC; Principal Investigator: Alexis Bozorg-Grayeli, MD, Hospital University Dijon-François Mitterrand

Publications and helpful links

Helpful Links

• oticon medical website

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Iteraural Time Difference
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: PIC_10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No