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

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ClinicalTrials.gov Identifier: NCT04357704
Recruitment Status : Withdrawn (Delay in setting up the study.)
First Posted : April 22, 2020
Last Update Posted : April 22, 2020
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

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
Hearing Loss, Cochlear Other: S0N0 Other: S0N500 Other: S-500N500 Other: S0N1000 Other: S0Nuncorr Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357704


Sponsors and Collaborators
Oticon Medical
Investigators
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Principal Investigator: Nicolas Guevara, MD Hospital University Nice-IUFC
Principal Investigator: Alexis Bozorg-Grayeli, MD Hospital University Dijon-François Mitterrand
Additional Information:
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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT04357704    
Other Study ID Numbers: PIC_10
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Oticon Medical:
Iteraural Time Difference
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms