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Early terminated due to COVID-19 public health emergency, with a patient population in vulnerable populations (older adults) seeking cochlear implantation as elective Standard of Care.
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| Name | Class |
|---|---|
| CogState Ltd. | INDUSTRY |
| Syneos Health | OTHER |
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This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Immediate Cochlear Implantation) | Experimental | Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. |
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| Group B (Delayed Cochlear Implantation) | Active Comparator | Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implantation | Device | Unilateral implantation with a commercially approved Nucleus cochlear implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hearing Handicap | The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. | 6 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David N Cade, MD, MBA | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Center for Neurosciences | Tucson | Arizona | 85718 | United States | ||
| House Ear Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A (Immediate Cochlear Implantation) | Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant |
| FG001 | Group B (Delayed Cochlear Implantation) | Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study terminated due to COVID 19
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A (Immediate Cochlear Implantation) | Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hearing Handicap | The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. | Data was not collected as the study was terminated due to COVID-19 | Posted | 6 months after enrollment |
|
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All Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed although there was 1 subject enrolled and withdrawn due to not meeting candidacy requirements and study was terminated due to COVID 19.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A (Immediate Cochlear Implantation) | Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PRS Specialist, Clinical Affairs | Cochlear Limited | +612 9428 6555 | cltd-prs-admin@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2019 | Sep 13, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2019 | Sep 13, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D006312 | Hearing Loss, Bilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D019929 | Cochlear Implantation |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
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| Los Angeles |
| California |
| 90057 |
| United States |
| Washington University | St Louis | Missouri | 63112 | United States |
| New York Eye and Ear Infirmary of Mount Sinai | New York | New York | 10029 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| University of Cincinnati Health | Cincinnati | Ohio | 45219 | United States |
| Ohio State University | Columbus | Ohio | 43212 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| BG001 | Group B (Delayed Cochlear Implantation) | Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Group B (Delayed Cochlear Implantation) | Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group B (Delayed Cochlear Implantation) | Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation. Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |