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Speech Perception Performance With Gap-interleaved Stimulation Paradigms

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ClinicalTrials.gov Identifier: NCT03937388
Recruitment Status : Completed
First Posted : May 3, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
University of Innsbruck / Department of Mechatronics
Information provided by (Responsible Party):
Angelica Perez Fornos, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE April 30, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE March 6, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Performance in standardized speech perception tests [ Time Frame: Day 1 ]
Consonant and word recognition tests
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2019)
Comparison of volume levels resulting in equal loudness perception [ Time Frame: Day 1 ]
Energetic efficiency of stimulation map
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 2, 2019)
Quality of hearing [ Time Frame: Day 1 ]
1-10 visual-analog scale
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Speech Perception Performance With Gap-interleaved Stimulation Paradigms
Official Title  ICMJE Effect of Gap-interleaved Stimulation Paradigms in Speech Perception Performance of Experienced Cochlear Implant Recipients: a Single-centre, Randomised Controlled Single-blinded Study
Brief Summary Cochlear implants (CI) are used to help patients with severe to profound hearing loss regain auditory perception by electrical stimulation of the auditory nerve. The electrical stimulation consists of trains of charge balanced, biphasic current pulses. For each patient, individual stimulation parameters (perception threshold, most comfortable level - MCL) are determined for each electrode during fitting sessions. However, an important parameter, pulse duration, cannot be individualized for each electrode. There are certain circumstances where it would be advantageous to have the possibility of introducing variable pulse durations into the fitting strategy (e.g., optimization of energy consumption, development of combined cochleo-vestibular implants). However, since in current CI systems pulses are transmitted sequentially, introducing varying pulse widths would also introduce "gaps" (zero-stimulation periods) into the stimulation profile. The influence of such auditory gaps on speech recognition and on the quality of hearing has not been explored yet, but can be investigated in current CI users. The objective of this study is to investigate the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.
Detailed Description

Auditory gaps can be induced in standard CI users by temporarily deactivating one to three electrodes. These gaps can be configured to have different gap durations.

The different variations of auditory stimulation with gaps will be presented to study participants via a standard MED-EL audio processor (Opus 2) bearing conformity marking. The programming of the processor will be performed using standard clinical hardware and software interfaces. These include the hardware interfaces "MAX interface box" and the "Diagnostic Interface Box" (DIB II) as well as the "MAESTRO" fitting software. After programming the respective configurations to the audio test-processor, a clinical word recognition test (Fournier) and a clinical consonant recognition test will be presented to the participants in a sound-shielded chamber using a free-field loudspeaker system.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Repeated measures, randomised, controlled, single blinded trial
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Deafness
  • Hearing Loss
Intervention  ICMJE Other: Cochlear stimulation strategy including time-fixed gaps
Investigation of the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.
Study Arms  ICMJE Experimental: Cochlear implant recipients
Intervention: Other: Cochlear stimulation strategy including time-fixed gaps
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2019)
8
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2019)
10
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent as documented by signature
  • CI recipients using MED-EL implants (C40+, Pulsar, Sonata, Concerto, or Synchrony) and standard electrode arrays (Standard, FLEXSOFT, FLEX28, or FLEX24)
  • >1 year post-implantation
  • Regular CI use (at least 4 hours/day)
  • At least 9 active electrodes in the device
  • Good knowledge of French (at least B1 level according to the Common European Framework of Reference for Languages)

Exclusion Criteria:

  • Patients with electro-acoustic stimulation (EAS) systems
  • Unwillingness or inability to perform investigational tests
  • Known or suspected drug or alcohol abuse
  • Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia, etc.)
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03937388
Other Study ID Numbers  ICMJE 2018-01938
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Angelica Perez Fornos, University Hospital, Geneva
Study Sponsor  ICMJE Angelica Perez Fornos
Collaborators  ICMJE University of Innsbruck / Department of Mechatronics
Investigators  ICMJE
Principal Investigator: Angelica Perez Fornos, PhD University Hospital, Geneva
PRS Account University Hospital, Geneva
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP