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Fundamental Asynchronous Stimulus Timing Sound Coding Study (FAST)

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ClinicalTrials.gov Identifier: NCT02698787
Recruitment Status : Completed
First Posted : March 4, 2016
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
Cochlear

Brief Summary:
The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.

Condition or disease Intervention/treatment
Sensorineural Hearing Loss Device: Experimental sound coding strategy (FAST) Device: Commercially available ACE sound coding strategy

Detailed Description:
The Fundamental Asynchronous Stimulus Timing (FAST) strategy offers excellent potential as a low power alternative coding strategy to the current default strategy in Nucleus® cochlear implants, Advanced Combination Encoder (ACE). Additionally, FAST offers potential bilateral benefits - localization and listening in spatially separated noise - because it has been shown in acute, controlled studies to provide more access to interaural timing difference (ITD) cues (Smith, 2010).Previous research with experienced cochlear-implant recipients has shown issues with conversion from ACE to FAST. The FAST strategy typically sounds very different in quality, and acclimatization can be lengthy. This extended adaptation time makes it difficult to show conclusively that FAST is non-inferior to ACE for speech understanding. A potential barrier to evaluating performance with FAST in current cochlear-implant recipients is the extensive amount of prior experience that many recipients have using ACE. Hence, there is a distinct need to evaluate FAST in newly implanted recipients.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients
Actual Study Start Date : December 2015
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.
Device: Experimental sound coding strategy (FAST)
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Device: Commercially available ACE sound coding strategy
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Experimental: Group 2
All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 2 will be the commercially available ACE (control) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 2 will be switched to the receiving intervention of the FAST (experimental) sound coding strategy. The experimental sound coding strategy will be used from 3-6 months post activation.
Device: Experimental sound coding strategy (FAST)
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Device: Commercially available ACE sound coding strategy
Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy




Primary Outcome Measures :
  1. Change in Open Set Monosyllabic Word Recognition Score [ Time Frame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months) ]

    Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct.

    The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct.


  2. Change in Signal-to-Noise Ratio (SRT) [ Time Frame: Visit 5 (3 Months) and Visit 8 (6 months) ]

    The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance.

    SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation.




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:   No
Criteria

Inclusion Criteria

  • Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant
  • Post-linguistically deafened
  • Native speaker of American English
  • Eighteen years of age or older

Exclusion Criteria

  • Previous or existing cochlear-implant recipient
  • Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Diagnosis of retro-cochlear pathology
  • Diagnosis of auditory neuropathy
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
  • Unwillingness or inability to comply with all investigational requirements
  • Additional cognitive handicaps that would delay rate of improvement with the cochlear implant

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): NCT02698787


Locations
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United States, Colorado
University of Colorado Health
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Cochlear
  Study Documents (Full-Text)

Documents provided by Cochlear:
Publications:
Daneman , M., & Carpenter, P.A. (1980). Individual differences in working memory and reading. Journal of Verbal Learning andVerbal Behavior, 19, 450-466.
Bench, J., Kowal, A., & Bamford, J. (1979). The BKB (Bench-Kowal-Bamford) sentence lists for partially-hearing children. British Journal of Audiology, 13, 108-112.Spahr, A. J., Dorman, M. F., Litvak, L. M., Van Wie, S., Gifford, R. H., Loizou, P. C., Loiselle, L. M., Oakes, T., & Cook, S. (2012).
Smith, Z. M. (2010). Improved sensitivity to interaural time differences with the FAST coding strategy. Presented at the 11th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Stockholm, Sweden.

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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02698787    
Other Study ID Numbers: CAM5621
First Posted: March 4, 2016    Key Record Dates
Results First Posted: February 2, 2021
Last Update Posted: February 2, 2021
Last Verified: January 2021
Keywords provided by Cochlear:
cochlear implant, sensorineural hearing loss
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases