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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02203305
Other study ID # 14-1544
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date September 16, 2021

Study information

Verified date February 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cochlear Implant
cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss
Other:
Control Group
Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.

Locations

Country Name City State
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill Med-El Corporation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271. — View Citation

Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d. — View Citation

Hansen MR, Gantz BJ, Dunn C. Outcomes after cochlear implantation for patients with single-sided deafness, including those with recalcitrant Ménière's disease. Otol Neurotol. 2013 Dec;34(9):1681-7. doi: 10.1097/MAO.0000000000000102. — View Citation

Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in Pitch Perception With the Cochlear Implant Over the Post-activation Period Participants completed an adaptive pitch matching task that compared the pitch of acoustic stimulation presented to their normal hearing ear with the perception of stimulation from the cochlear implant. Two stimuli were used: clicks & tones. Pitch perception was evaluated for the 5 most apical electrodes. A normalized score was obtained (normalized score = geometric mean of the responses / electric center frequency of the evaluated electrode); that is, the normalized score = perceived frequency / frequency information presented by the electrode. Results are reported as the averaged normalized score for clicks & tones for each electrode (electrodes 1-5) at each interval (1, 3, 6, and 12 months post-activation). A value of 1.0 indicates the participant perceived the same frequency as the center frequency presented by the electrode. A value < 1.0 indicates a lower perceived pitch and a value > 1.0 indicates a higher perceived pitch than the electric frequency information. post-activation period (1, 3, 6, and 12 months post-activation)
Primary Change in Word Recognition in Quiet Over Time Results on recorded speech perception materials: monosyllabic (Consonant-Nucleus-Consonant) words in quiet during the first year of device use. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Localization Results (Measured in Root-mean-squared (RMS) Error) Over Time Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Subjective Benefit (Measured With the Speech, Spatial, and Qualities (SSQ) of Hearing Questionnaire) Over Time Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Sentence Recognition in Noise Over Time, Measured With the AzBio Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the normal/better hearing ear. Scored as the percent correctly repeated. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Localization Results (Measured in Variable Error) Over Time Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in variable error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Localization Results (Measured in Constant Error) Over Time Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Localization Results (Measured in Adjusted Constant Error) Over Time Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in adjusted constant error. A lower value indicates better performance. Results are compared during the first year of cochlear implant use. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire) Over Time Subjects completed subjective questionnaires in order to evaluate the perceived benefits of cochlear implantation. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) of Hearing Questionnaire) Over Time Subjects completed subjective questionnaires to order to evaluate the perceived benefits of cochlear implantation. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear) Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 10-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as the percent correctly repeated. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Sentence Recognition in Noise Over Time, Measured With AzBio Sentences With Speech and Noise Presented From the Front Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 10-talker masker from the front speaker. Scored as the percent correctly repeated. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech and Noise Presented From the Front Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) and the 4-talker masker from the front speaker. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower numbers indicate better performance (range -7.5 to 23.5 dB SNR). Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Better Hearing Ear Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the normal/better hearing ear. Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. A lower value indicates better performance (range -7.5 to 23.5 dB SNR). Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Primary Change in Sentence Recognition in Noise Over Time, Measured With Bamford-Kowal-Bamford (BKB) Sentences With Speech Presented From the Front and Noise Towards the Poorer Hearing Ear (Implanted Ear) Results on recorded speech perception materials: sentence recognition in noise with the target (speaker) from the front and the 4-talker masker 90 degrees towards the poorer hearing ear (implanted ear). Scored as dB signal-to-noise ratio that the listener gets 50% speech understanding. Lower values indicate better performance (range -7.5 to 23.5 dB SNR). Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Secondary Aided Word Recognition With a Cochlear Implant Versus a Current Treatment Option (i.e., Hearing Aid) Results on recorded speech perception materials: aided word recognition. Recorded 50-word CNC words were evaluated preoperatively with a conventional hearing aid. Performance was compared to the CI alone at the 12 month interval. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis to control for potential floor or ceiling effects (e.g., scores <20%). preoperative interval and 12 month post-activation interval
Secondary Localization Abilities With a Cochlear Implant Versus a Current Treatment Option (i.e., Bone-conduction Device) Subjects were asked to identify the noise source from an 11-speaker array with the cochlear implant on versus with a bone-conduction device. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Secondary Subjective Benefit (Measured With the Abbreviated Profile of Hearing Aid Benefit Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales. preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)
Secondary Subjective Benefit (Measured With the Tinnitus Handicap Inventory (THI) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) Subjects completed subjective questionnaires. For the Tinnitus Handicap Inventory, participants rank their perceived tinnitus severity on a scale of 0-100, with lower values indicate less tinnitus severity. Responses across all questions are summed to derive the total score. Intervals within the first year of device use (e.g., preoperative, and 1-, 3-, 6-, 9-, and 12-months post-activation)
Secondary Subjective Benefit (Measured With the Speech, Spatial, and Qualities of Hearing (SSQ) Questionnaire) With Cochlear Implant Versus Preoperative Perceptions With Alternative Treatment Options (e.g., Hearing Aid, Bone-conduction Device) Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire. preoperative interval, and post-activation intervals (1, 3, 6, 9, and 12 months)
Secondary Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise Front) Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. preoperative interval and 12 month post-activation interval
Secondary Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Poorer Hearing Ear) Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. preoperative interval and 12 month post-activation interval
Secondary Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (AzBio, Speech Front and Noise to the Better Hearing Ear) Recorded AzBio sentences in a 10-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Percent correct data were converted to rationalized arcsine units (RAU) prior to data analysis. preoperative interval and 12 month post-activation interval
Secondary Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-Speech In Noise (SIN), Speech Front and Noise Front) Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). preoperative interval and 12 month post-activation interval
Secondary Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Poorer Hearing Ear) Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). preoperative interval and 12 month post-activation interval
Secondary Speech Perception Outcomes With a Cochlear Implant Versus a Bone-conduction Device: Sentence Recognition in Noise (BKB-SIN, Speech Front and Noise to the Better Hearing Ear) Recorded BKB sentences in a 4-talker masker were evaluated in 2 conditions: 1) bone-conduction device at the preoperative interval and 2) with the cochlear implant (CI) at the 12-month post-activation period. A paired samples t-test compared the performance with the two devices. Results are reported in dB SNR, where a lower value indicates better performance (range -7.5 to 23.5 dB SNR). preoperative interval and 12 month post-activation interval
Secondary Speech Recognition in Noise for a Control Group: AzBio Sentences (0 dB SNR) The speech perception (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 10-talker masker at 0 dB SNR with the target speech presented from the front and the masker (1) presented from the front (SoNo), (2) presented towards the implanted ear (SoNbc), and (3) presented towards the acoustic ear (SoNnh). Performance was scored as the percent of words correctly repeated, with higher values indicating better performance. The task was completed with the participants listening with their bone-conduction device on versus off. Assessment completed after 12 months of implantable bone-conduction listening experience
Secondary Speech Recognition in Noise for a Control Group: BKB-SIN Test The speech perception outcomes in the study population (cochlear implant recipients with UHL/SSD) to a control group of implantable bone-conduction device recipients (alternative treatment option). Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation. Sentence recognition was assessed in a 4-talker masker with the target speech presented from the front and the masker (1) presented from the front, (2) presented towards the implanted ear, and (3) presented towards the acoustic ear. Performance was scored as the dB SNR when the participant understood 50% correct, with lower values indicating better performance. Participants completed the task with the device on and off. Assessment completed after 12 months of implantable bone-conduction listening experience
Secondary Localization for a Control Group Subjects were asked to identify the noise source from an 11-speaker array with the bone-conduction device on versus off. The intensity level of the stimulus was randomly varied (10 dB around 70 dB SPL) to limit the listener relying on level effects. Responses at each intensity level (i.e., 60, 70, and 80 dB SPL) for a given sound source (speaker) were combined (averaged). Results are reported in root-mean-squared (RMS) error. A lower value indicates better performance. Subjects in the control group were implantable bone-conduction device recipients (alternative treatment option) with at least 12 months of listening experience with their implanted bone-conduction device. Participants completed the task with their device on and off. Assessment completed after 12 months of implantable bone-conduction listening experience
Secondary Subjective Benefit for a Control Group: Speech, Spatial, and Qualities of Hearing Scale (SSQ) Subjects completed subjective questionnaires. For the Speech, Spatial, and Qualities of hearing questionnaire, participants rank their perceived abilities on a scale of 0-10. Higher values indicate more perceived abilities. Results are reported as the average responses across questions for each subscale (Speech Hearing, Spatial Hearing, and Qualities of Hearing). Results are also reported as the total score at each interval, which is the average of the responses from all questions for the questionnaire.
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
Assessment completed after 12 months of implantable bone-conduction listening experience
Secondary Subjective Benefit for a Control Group: Abbreviated Profile of Hearing Aid Benefit (APHAB) Subjects completed subjective questionnaires. For the Abbreviated Profile of Hearing Aid Benefit, participants rank their perceived difficulty on a scale of 1-99, with lower values indicate less perceived difficulty. Results are reported as the average responses for each of the four subscales: ease of communication, reverberation, effectiveness in background noise, and reverberation. The global score is the average response across questions for the ease of communication, reverberation, and effectiveness in background noise subscales.
Participants in the control group had at least 12 months of listening experience with their implanted bone-conduction device prior to study participation.
Assessment completed after 12 months of implantable bone-conduction listening experience
See also
  Status Clinical Trial Phase
Recruiting NCT04793412 - Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial N/A