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Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear

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ClinicalTrials.gov Identifier: NCT03867396
Recruitment Status : Enrolling by invitation
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE February 19, 2019
First Posted Date  ICMJE March 8, 2019
Last Update Posted Date March 8, 2019
Actual Study Start Date  ICMJE January 23, 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from in front of the person (Front) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #4 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant Alone, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #5 will assess how well the listener can hear wearing only his/her cochlear implant while listening to sentences coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #6 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #7 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #8 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #9 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #10 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid in the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #11 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #12 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #13 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise coming from all directions (Omni). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #14 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Signal to Noise Ratio (SNR) threshold obtained from IEEE sentence in noise test. Condition: Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #15 will assess how well the listener can hear wearing his/her cochlear implant and CROS on the non-implanted ear while listening to sentences coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #16 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #17 will ask the subject how difficult it was to listen to speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #18 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #19 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant Alone, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with only his/her cochlear implant. Outcome #20 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #21 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #22 will ask the subject how difficult it was to listen to speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #23 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #24 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and hearing aid in the non-implanted ear. Outcome #25 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #26 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #27 will ask the subject how difficult it was to listen to speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #28 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #29 will ask the subject how difficult it was to listen to speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Listening effort rating. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how difficult it was to listen to the sentences presented in the test with his/her cochlear implant and CROS on the non-implanted ear. Outcome #30 will ask the subject how difficult it was to listen to speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being extremely difficult and 100 being very easy. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #31 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #32 will assess speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #33 will assess speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #34 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant Alone, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using only his/her cochlear implant on an everyday basis. Outcome #35 will assess speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #36 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #37 will assess speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #38 will assess speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #39 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with Hearing Aid in non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and hearing aid in the non-implanted ear on an everyday basis. Outcome #40 will assess speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #41 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Ipsilateral, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #42 will assess speech coming from the same side of the implant (Ipsilateral) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Omni [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #43 will assess speech coming from in front of the person (Front) with competing noise coming from all directions (Omni). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Contralateral, Noise Ipsilateral [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #44 will assess speech coming from the opposite side of the implant (Contralateral) with competing noise coming from the side of the implant (Ipsilateral). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
  • Questionnaire: Acceptability ratings. Cochlear Implant with CROS on non-implanted ear, Speech Front, Noise Front [ Time Frame: 12 minutes ]
    Following each IEEE noise test, the subject will rate how acceptable it would be for the subject to listen in the conditions of the test using his/her cochlear implant and CROS on the non-implanted ear on an everyday basis. Outcome #45 will assess speech coming from in front of the person (Front) with competing noise also coming from in front of the person (Front). The rating scale is 0-100, 0 being Not at All Preferred and 100 being Very Preferred. Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Official Title  ICMJE Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear
Brief Summary

Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.

This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hearing Loss, Sensorineural
Intervention  ICMJE
  • Device: CROS
    Advanced Bionics CROS
  • Device: Hearing Aid
    Advanced Bionics Naida hearing aid
  • Other: Cochlear Implant Alone
    No hearing device on contralateral ear
Study Arms  ICMJE
  • Active Comparator: Cochlear Implant and Hearing Aid
    Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests.
    Intervention: Device: Hearing Aid
  • Active Comparator: Cochlear Implant alone
    Subject only uses the cochlear implant; hearing on the contralateral side is unaided.
    Intervention: Other: Cochlear Implant Alone
  • Experimental: Cochlear Implant and CROS
    Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device.
    Intervention: Device: CROS
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: March 5, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria*:

  • An Advanced Bionics cochlear implant recipient with at least 12 months of listening experience
  • Low frequency PTA

Exclusion Criteria*:

  • Non-English speakers

    • Additional Inclusion and Exclusion criteria apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03867396
Other Study ID Numbers  ICMJE 18-1101
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: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared with Advanced Bionics.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: From first patient through IRB study close.
Access Criteria: The de-identified data will be shared to with Advanced Biionics in a password protected Excel sheet downloaded from research database.
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melinda Anderson, PhD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date March 2019

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