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

Sponsor
Oticon Medical (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04357704
Collaborator
(none)
0
2
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: S0N0
  • Other: S0N500
  • Other: S-500N500
  • Other: S0N1000
  • Other: S0Nuncorr
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User
Anticipated Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Sep 1, 2019

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

    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.

Secondary Outcome Measures

  1. speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners [day 0]

    SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.

  2. ITD sensitivity in bilateral cochlear implant user [day 0]

    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.

  3. Preferred jitter in bilateral cochlear implant user [day 0]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oticon Medical

Investigators

  • Principal Investigator: Nicolas Guevara, MD, Hospital University Nice-IUFC
  • Principal Investigator: Alexis Bozorg-Grayeli, MD, Hospital University Dijon-François Mitterrand

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Oticon Medical
ClinicalTrials.gov Identifier:
NCT04357704
Other Study ID Numbers:
  • PIC_10
First Posted:
Apr 22, 2020
Last Update Posted:
Apr 22, 2020
Last Verified:
Nov 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oticon Medical
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2020