Trial Outcomes & Findings for Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss (NCT NCT02963974)
NCT ID: NCT02963974
Last Updated: 2021-08-06
Results Overview
Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval.
COMPLETED
NA
20 participants
up to 24 months post-activation
2021-08-06
Participant Flow
Participant milestones
| Measure |
Cochlear Implant
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Baseline characteristics by cohort
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Age, Continuous
|
5.5 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Ear Affected
Left Ear
|
10 Participants
n=5 Participants
|
|
Ear Affected
Right Ear
|
10 Participants
n=5 Participants
|
|
Etiology of Hearing Loss
Unknown
|
12 Participants
n=5 Participants
|
|
Etiology of Hearing Loss
Congenital Cytomegalovirus
|
3 Participants
n=5 Participants
|
|
Etiology of Hearing Loss
Mondini Malformation
|
2 Participants
n=5 Participants
|
|
Etiology of Hearing Loss
Infection
|
1 Participants
n=5 Participants
|
|
Etiology of Hearing Loss
Trauma
|
1 Participants
n=5 Participants
|
|
Etiology of Hearing Loss
Waardenburg Syndrome
|
1 Participants
n=5 Participants
|
|
Suspected Length of Deafness
|
3.3 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 months post-activationPopulation: One participant was lost to follow-up after Month 12
Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Pre-operatively
|
1.4 percentage of words correct
Standard Deviation 6.3
|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Month 3
|
14.4 percentage of words correct
Standard Deviation 14.5
|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Month 6
|
28.2 percentage of words correct
Standard Deviation 18.0
|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Month 9
|
45.0 percentage of words correct
Standard Deviation 15.2
|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Month 12
|
50.3 percentage of words correct
Standard Deviation 33.1
|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Month 18
|
51.8 percentage of words correct
Standard Deviation 11.3
|
|
Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Month 24
|
58.6 percentage of words correct
Standard Deviation 15.4
|
PRIMARY outcome
Timeframe: 6 months post-activationTwo ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation
Device off to device on with speech and noise in front
|
1.8 signal-to-noise ratio
Interval 0.4 to 3.2
|
|
Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation
Device off to device on with speech in front and noise to the implanted side
|
0.4 signal-to-noise ratio
Interval -1.2 to 1.9
|
|
Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation
Device off to device on with speech in front and noise to the normal side
|
1.9 signal-to-noise ratio
Interval 0.4 to 3.5
|
PRIMARY outcome
Timeframe: 12 months post-activationTwo ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation
Device on with speech and noise in front
|
1.6 signal-to-noise ratio
Interval 0.5 to 2.7
|
|
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation
Device off to device on with speech in front and noise to the implanted side
|
2.5 signal-to-noise ratio
Interval 1.1 to 3.9
|
|
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation
Device off to device on with speech in front and noise to the normal side
|
3.5 signal-to-noise ratio
Interval 1.8 to 5.2
|
PRIMARY outcome
Timeframe: 24 months post-activationPopulation: One participant was lost to follow-up after Month 12
Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Outcome measures
| Measure |
Cochlear Implant
n=19 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use
Device off to device on with speech and noise in front
|
1.4 signal-to-noise ratio
Interval -0.1 to 2.8
|
|
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use
Device off to device on with speech in front and noise to the implanted side
|
1.7 signal-to-noise ratio
Interval 0.0 to 3.4
|
|
Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use
Device off to device on with speech in front and noise to the normal side
|
4.0 signal-to-noise ratio
Interval 2.6 to 5.4
|
PRIMARY outcome
Timeframe: 3 months post-activationSoundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
Overall RMS error from device off to device on
|
14.7 degrees
Interval 3.5 to 31.8
|
|
Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
Random error from device off to device on
|
-0.8 degrees
Interval -5.1 to 9.3
|
|
Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
Constant error from device off to device on
|
18.8 degrees
Interval 4.0 to 32.2
|
|
Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
Adjusted constant error from device off to device on
|
19.1 degrees
Interval 3.0 to 26.0
|
PRIMARY outcome
Timeframe: 9 months post-activationSoundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
Overall RMS error from device off to device on
|
24.6 degrees
Interval 16.9 to 28.2
|
|
Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
Random error from device off to device on
|
15.8 degrees
Interval 8.2 to 18.5
|
|
Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
Constant error from device off to device on
|
27.9 degrees
Interval 8.3 to 35.1
|
|
Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
Adjusted constant error from device off to device on
|
24.9 degrees
Interval 7.6 to 33.0
|
PRIMARY outcome
Timeframe: 18 months post-activationPopulation: One participant was lost to follow-up after Month 12
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Outcome measures
| Measure |
Cochlear Implant
n=19 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
RMS error from device off to device on
|
37.7 degrees
Interval 18.0 to 50.5
|
|
Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
Random error from device off to device on
|
20.2 degrees
Interval 11.2 to 24.6
|
|
Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
Constant error from device off to device on
|
27.5 degrees
Interval 15.6 to 46.9
|
|
Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
Adjusted constant error from device off to device on
|
24.9 degrees
Interval 11.4 to 39.1
|
PRIMARY outcome
Timeframe: 24 months post-activationPopulation: One participant was lost to follow-up after Month 12
Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Outcome measures
| Measure |
Cochlear Implant
n=19 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
RMS error from device off to device on
|
35.1 degrees
Interval 15.1 to 47.0
|
|
Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
Random error from device off to device on
|
17.9 degrees
Interval 7.6 to 28.4
|
|
Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
Constant error from device off to device on
|
25.8 degrees
Interval 9.3 to 39.3
|
|
Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
Adjusted constant error from device off to device on
|
21.1 degrees
Interval 8.9 to 39.9
|
PRIMARY outcome
Timeframe: Pre-operatively through 24 months post-activationPopulation: One participant was lost to follow-up after Month 12
The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Speech: pre-operative to 3-month post-activation interval
|
1.4 score on a scale
Interval 0.1 to 2.7
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Speech: 3-month to 6-month post-activation interval
|
0.7 score on a scale
Interval -0.1 to 1.5
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Speech: 3-month to 9-month post-activation interval
|
0.6 score on a scale
Interval -0.3 to 1.4
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Speech: 3-month to 12-month post-activation interval
|
0.7 score on a scale
Interval -0.1 to 1.6
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Speech: 3-month to 18-month post-activation interval
|
0.8 score on a scale
Interval 0.0 to 1.6
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Speech: 3-month to 24-month post-activation interval
|
0.9 score on a scale
Interval -0.1 to 1.9
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Spatial: pre-operative to 3-month post-activation interval
|
2.6 score on a scale
Interval 0.9 to 4.2
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Spatial: 3-month to 6-month post-activation interval
|
0.8 score on a scale
Interval -0.4 to 1.9
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Spatial: 3-month to 9-month post-activation interval
|
1.0 score on a scale
Interval -0.3 to 2.3
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Spatial: 3-month to 12-month post-activation interval
|
1.3 score on a scale
Interval -0.1 to 2.6
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Spatial: 3-month to 18-month post-activation interval
|
1.7 score on a scale
Interval 0.5 to 2.9
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Spatial: 3-month to 24-month post-activation interval
|
1.1 score on a scale
Interval -0.5 to 2.8
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Qualities: pre-operative to 3-month post-activation interval
|
1.0 score on a scale
Interval 0.1 to 2.0
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Qualities: 3-month to 6-month post-activation interval
|
0.6 score on a scale
Interval -0.3 to 1.5
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Qualities: 3-month to 9-month post-activation interval
|
0.5 score on a scale
Interval -0.4 to 1.4
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Qualities: 3-month to 12-month post-activation interval
|
0.5 score on a scale
Interval -0.4 to 1.4
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Qualities: 3-month to 18-month post-activation interval
|
0.9 score on a scale
Interval 0.0 to 1.9
|
|
Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Qualities: 3-month to 24-month post-activation interval
|
0.4 score on a scale
Interval -0.5 to 1.4
|
PRIMARY outcome
Timeframe: Pre-operatively through 24 months post-activationPopulation: One participant was lost to follow-up after Month 12
Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
Pre-operative to 3-month post-activation interval
|
1.9 score on a scale
Interval 0.8 to 3.0
|
|
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
3-month to the 6-month post-activation interval
|
0.7 score on a scale
Interval 0.0 to 1.4
|
|
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
3-month to the 9-month post-activation interval
|
0.9 score on a scale
Interval 0.2 to 1.6
|
|
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
3-month to the 12-month post-activation interval
|
1.4 score on a scale
Interval 0.7 to 2.1
|
|
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
3-month to the 18-month post-activation interval
|
1.5 score on a scale
Interval 0.8 to 2.2
|
|
Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
3-month to the 24-month post-activation interval
|
1.4 score on a scale
Interval 0.7 to 2.1
|
PRIMARY outcome
Timeframe: Pre-operatively through 24 months post-activationPopulation: One participant was lost to follow-up after Month 12
PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue.
Outcome measures
| Measure |
Cochlear Implant
n=20 Participants
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
General Fatigue: pre-operative to 3-month post-activation
|
5.4 score on a scale
Interval -4.2 to 15.1
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
General Fatigue: 3-month to 6-month post-activation
|
4.6 score on a scale
Interval -5.1 to 14.2
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
General Fatigue: 3-month to 9-month post-activation
|
1.9 score on a scale
Interval -7.8 to 11.5
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
General Fatigue: 3-month to 12-month post-activation
|
2.5 score on a scale
Interval -71.0 to 12.2
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
General Fatigue: 3-month to 18-month post-activation
|
-1.0 score on a scale
Interval -10.8 to 8.8
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
General Fatigue: 3-month to 24-month post-activation
|
4.0 score on a scale
Interval -5.8 to 13.8
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Sleep Fatigue: Pre-operative to 3-month post-activation
|
3.5 score on a scale
Interval -5.6 to 12.7
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Sleep Fatigue: 3-month to 6-month post-activation
|
6.5 score on a scale
Interval -2.6 to 15.6
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Sleep Fatigue: 3-month to 9-month post-activation
|
2.7 score on a scale
Interval -6.4 to 11.8
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Sleep Fatigue: 3-month to 12-month post-activation
|
2.7 score on a scale
Interval -6.4 to 11.8
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Sleep Fatigue: 3-month to 18-month post-activation
|
4.2 score on a scale
Interval -5.1 to 13.4
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Sleep Fatigue: 3-month to 24-month post-activation
|
3.5 score on a scale
Interval -5.7 to 12.8
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Cognitive Fatigue: Pre-operative to 3-month post-activation
|
7.5 score on a scale
Interval -3.4 to 18.4
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Cognitive Fatigue: 3-month to 6-month post-activation
|
3.3 score on a scale
Interval -7.5 to 14.2
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Cognitive Fatigue: 3-month to 9-month post-activation
|
0.8 score on a scale
Interval -10.0 to 11.7
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Cognitive Fatigue: 3-month to 12-month post-activation
|
-2.3 score on a scale
Interval -13.2 to 8.6
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Cognitive Fatigue: 3-month to 18-month post-activation
|
1.7 score on a scale
Interval -9.3 to 12.8
|
|
Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Cognitive Fatigue: 3-month to 24-month post-activation
|
-2.2 score on a scale
Interval -13.2 to 8.8
|
Adverse Events
Cochlear Implant
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cochlear Implant
n=20 participants at risk
Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss
Cochlear implant: Implantation
|
|---|---|
|
Ear and labyrinth disorders
Facial stimulation
|
10.0%
2/20 • Number of events 2 • From the time of surgery through the Month 24 visit, a total of up to 25 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 1 • From the time of surgery through the Month 24 visit, a total of up to 25 months
|
|
General disorders
Fall
|
5.0%
1/20 • Number of events 1 • From the time of surgery through the Month 24 visit, a total of up to 25 months
|
|
General disorders
Sensory processing disorder
|
5.0%
1/20 • Number of events 1 • From the time of surgery through the Month 24 visit, a total of up to 25 months
|
|
Ear and labyrinth disorders
Hearing loss progression in contralateral ear
|
5.0%
1/20 • Number of events 1 • From the time of surgery through the Month 24 visit, a total of up to 25 months
|
Additional Information
Lisa Park, AuD, CCC-A
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place