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Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study

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ClinicalTrials.gov Identifier: NCT00594061
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Bruce J Gantz, University of Iowa

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Intervention Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Hide Arm/Group Description

There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Hide Arm/Group Description

There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
9
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
5
  55.6%
Male
4
  44.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
 100.0%
Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants
2.6  (5.5)
[1]
Measure Description: The IT-MAIS is a structured interview schedule used to assess the child’s spontaneous responses to sound in his/her everyday environment. It consists of 10 questions with a total scale range of 0-40. Performance is scored in terms of the total number of points accrued out of 40 possible points. Higher score indicates better performance. Each question has a potential of 0 (lowest) to 4 (highest) points.
MacArthur Communicative Developmental Inventories (CDI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 9 participants
10.4  (2.19)
[1]
Measure Description: The CDI is a parent report measure evaluating children's communicative development. The CDI Words and Gestures (WG) tests children aged 8- to 16-months. WG assesses the child's production of language by their responses to familiar words and phases. Raw scores are converted into age-equivalent scores.The maximum range of age equivalent scores is <8 months to 18 months. Higher age-equivalent scores indicate better outcomes.
Minnesota Child Development Inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 9 participants
11.3  (2.6)
[1]
Measure Description: This parent inventory consists of 54 statements describing the behaviors of infants and preschool-age children and provides measures of the child's expressive language development. The parent is asked yes/no questions and indicates whether the child is able to do what the statement says. Raw scores are converted into age-equivalent scores. The maximum range of age equivalent scores is 1 month to 63 months. Higher age-equivalent scores indicates better performance.
Preschool Language Scale-3   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 9 participants
74.2  (8.1)
[1]
Measure Description: Assesses global language skills using toys and pictures. This test assess auditory comprehension and expressive communication and a total language score is calculated. A higher total score indicates better performance. The standard score ranges from 50 to 150. A raw score for total language is calculated and converted into a standard score.
1.Primary Outcome
Title Pre-school Language Test
Hide Description Assesses global language skills using toys and pictures. This test assess auditory comprehension and expressive communication and a total language score is calculated. The reported score was assessed at 48 months post-implantation. The total language standard score ranges from 50-150. A higher total score indicates better performance. A raw score for total language is calculated and converted into a standard score.
Time Frame 48 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Hide Arm/Group Description:

There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
82.4  (22.7)
2.Secondary Outcome
Title Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral
Hide Description PB-K Test was constructed to be an open-set test of word understanding for children. It is scored as a percentage of words correct. The test was measured using the Iowa/Nucleus 10/10 mm and Nucleus Freedom together, the Iowa/Nucleus 10/10 mm only, and the Nucleus Freedom electrode only conditions. The higher the score, the better the word understanding. The post-operative time point for this score was reported on average at 56 months post-implantation.
Time Frame 56 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Hide Arm/Group Description:

There is no arm to this study--(each participant serves as his or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

Overall Number of Participants Analyzed 8
Mean (Standard Error)
Unit of Measure: percentage of words correct
bilateral 85.7  (3.31)
short electrode 55.6  (7.9)
long electrode 85.9  (2.33)
Time Frame Following surgical implantation of the device and longitudinally at 4, 8, 12, 18, and 24 months, and annually thereafter through five years of age.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Hide Arm/Group Description

There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation: Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

All-Cause Mortality
Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Affected / at Risk (%)
Total   2/9 (22.22%) 
Ear and labyrinth disorders   
Failed device * [1]  1/9 (11.11%) 
Failed Device * [2]  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
[1]
Nine months post-implantation the child was seen in our clinic for swelling on his right cochlear implant site. The child underwent explantation of the device on his right side and was later re-implanted with a second Nucleus Freedom device.
[2]
Due to asymmetry in speech perception scores and electrical shorts with device, explantation of the device and reimplantation with a different device was recommended. Device failure report indicated a failed device due to electrode lead malfunction.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Affected / at Risk (%)
Total   0/9 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bruce Gantz
Organization: University of Iowa
Phone: 319-353-8776
EMail: bruce-gantz@uiowa.edu
Layout table for additonal information
Responsible Party: Bruce J Gantz, University of Iowa
ClinicalTrials.gov Identifier: NCT00594061     History of Changes
Other Study ID Numbers: 200710716
First Submitted: January 3, 2008
First Posted: January 15, 2008
Results First Submitted: October 26, 2017
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018