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CHANGE Feasibility Study (CLTD5626)

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ClinicalTrials.gov Identifier: NCT02671032
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : March 4, 2020
Sponsor:
Collaborators:
The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital
Information provided by (Responsible Party):
Cochlear

Brief Summary:
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.

Condition or disease Intervention/treatment Phase
Hearing Loss Device: Nucleus CI532 cochlear implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
Actual Study Start Date : January 5, 2016
Actual Primary Completion Date : July 15, 2019
Actual Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Implantation with Nucleus CI532 cochlear implant
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Device: Nucleus CI532 cochlear implant



Primary Outcome Measures :
  1. Report on degree of hearing as measured by pure tone audiogram [ Time Frame: 6 months post activation ]
    unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.

  2. Report on clinical performance in quiet and noise [ Time Frame: 6 months post activation ]
    speech perception assessment with monosyllabic words and sentences in competing noise at a fixed signal-to-noise ratio (+5dB).

  3. Report of medical/surgical and device related adverse events. [ Time Frame: 12 months post activation. ]
    Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.


Secondary Outcome Measures :
  1. Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing scale (SSQ) [ Time Frame: 6 months post activation ]
    Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation.

  2. Glasgow Benefit Inventory (GBI). [ Time Frame: 6 months post activation ]
    Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet current cochlear implant indications at the implanting centre
  2. In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted.
  3. Fluent speaker in the local language used to assess clinical performance
  4. Eighteen years of age or older at the time of implantation with no upper age limit

Exclusion Criteria:

  1. Evidence of hearing loss prior to 5 years of age.
  2. Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
  3. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
  4. Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
  5. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
  6. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
  7. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
  8. Active middle-ear infection,
  9. Tympanic membrane perforation
  10. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices
  11. Unwillingness or inability of the candidate to comply with all investigational requirements.
  12. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
  13. Patients with recurrent episodes of bacterial meningitis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671032


Locations
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Australia, Victoria
The Hearing Cooperative Research Centre
Carlton, Victoria, Australia, 3053
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia, 30002
Sponsors and Collaborators
Cochlear
The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital
Investigators
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Principal Investigator: Robert Cowan, DipAud PhD HEARing CRC
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Responsible Party: Cochlear
ClinicalTrials.gov Identifier: NCT02671032    
Other Study ID Numbers: CLTD5626
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.
Keywords provided by Cochlear:
Cochlear Prosthesis Implantation
Additional relevant MeSH terms:
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Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases