Hearing LossCLTD5626NCT02671032

CHANGE Feasibility Study

A study testing Nucleus CI532 cochlear implant in people with Hearing Loss, run by Cochlear at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss
What is being tested?: Nucleus CI532 cochlear implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 2 sitesAustralia
Study dates: 5 Jan 2016to 15 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet current cochlear implant indications at the implanting centre
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.
Fluent speaker in the local language used to assess clinical performance
Eighteen years of age or older at the time of implantation with no upper age limit

Who cannot join

Evidence of hearing loss prior to 5 years of age.
Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
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.

Show all 13Show fewer

Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway.
Active middle-ear infection,
Tympanic membrane perforation
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
Unwillingness or inability of the candidate to comply with all investigational requirements.
Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak.
Patients with recurrent episodes of bacterial meningitis.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

The Hearing Cooperative Research Centre
Carlton, Victoria, 3053
Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 30002

Other trials in Australia

About this study

Official title: Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.

Conditions: Hearing Loss
Being tested: Nucleus CI532 cochlear implant
Keywords: Cochlear Prosthesis Implantation
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nucleus CI532 cochlear implantDevice

Study groups in NCT02671032
Study group	Role	What they receive
Implantation with Nucleus CI532 cochlear implant	Experimental	All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant. Receives: Device: Nucleus CI532 cochlear implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Report on Degree of Hearing as Measured by Pure Tone Audiogram
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Measured: 6 months and 12 months post activation
Report on Clinical Performance in Quiet and Noise
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Measured: 3 months, 6 months and 12 months post activation
Report of Medical/Surgical and Device Related Adverse Events.
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
Measured: 12 months post activation.

Secondary outcomes (2)

Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.
Measured: Preoperative and 6 months post activation
Glasgow Benefit Inventory (GBI).
Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.
Measured: 6 months post activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 201615 Jul 2019

First posted2 Feb 2016 (estimated)
Study start5 Jan 2016
Primary completion15 Jul 2019
Study completion15 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02671032
Sponsor's protocol ID: CLTD5626
Acronym: CLTD5626
Status last verified: Jun 2021
First submitted: 27 Jan 2016
Last updated: 9 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation

All Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterisation of Audiological Outcomes With the Nucleus CI532 Cochlear Implant in Adult Subjects.
ClinicalTrials.gov ID: NCT02671032
Acronym / sponsor ID: CLTD5626 / CLTD5626
Conditions: Hearing Loss
Keywords: Cochlear Prosthesis Implantation
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Collaborators: The Hearing Cooperative Research Centre, Royal Victoria Eye and Ear Hospital
Study start: 5 Jan 2016 (actual)
Primary completion: 15 Jul 2019 (actual)
Study completion: 15 Jul 2019 (actual)
First posted: 2 Feb 2016 (estimated)
Results: Posted 20 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Implantation with Nucleus CI532 cochlear implant	Experimental	Device: Nucleus CI532 cochlear implantAll participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Meet current cochlear implant indications at the implanting centre
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.
Fluent speaker in the local language used to assess clinical performance
Eighteen years of age or older at the time of implantation with no upper age limit

Key exclusion criteria (13 listed)

Evidence of hearing loss prior to 5 years of age.
Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above.
Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted.
Additional disabilities that may affect the subject's participation or safety during the clinical investigation.
Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nucleus CI532 cochlear implant	Device	Implantation with Nucleus CI532 cochlear implant

Primary outcome

Report on Degree of Hearing as Measured by Pure Tone Audiogram
Time frame: 6 months and 12 months post activation
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Report on Clinical Performance in Quiet and Noise
Time frame: 3 months, 6 months and 12 months post activation
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
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.

2 secondary outcomes

Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Time frame: Preoperative and 6 months post activation
Glasgow Benefit Inventory (GBI).
Time frame: 6 months post activation

Results and safety

Results posted to the registry on 20 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Implantation With Nucleus CI532 Cochlear Implant	12	12

Primary outcome: Report on Degree of Hearing as Measured by Pure Tone Audiogram

Time frame: 6 months and 12 months post activation. Number. Unit: participants

Measure	Implantation With Nucleus CI532 Cochlear Implant n = 12
6 months, 250 Hz : Function <= 70 dB HL	5
6 months, 250 Hz : Preserved 70 > dB HL <= 90	2
6 months, 250 Hz : Preserved > 90 dB HL	2
6 months, 500 Hz : Function <= 70 dB HL	0
6 months, 500 Hz : Preserved 70 > dB HL <= 90	4
6 months, 500 Hz : Preserved > 90 dB HL	4
6months, 750 Hz : Function <= 70 dB HL	0
6months, 750 Hz : Preserved 70 > dB HL <= 90	4

Primary outcome: Report on Clinical Performance in Quiet and Noise

Time frame: 3 months, 6 months and 12 months post activation. Mean (Standard Deviation). Unit: percentage of correct words

Measure	Implantation With Nucleus CI532 Cochlear Implant n = 12
Quiet baseline, untreated ear	22 (15.4)
Baseline quiet, treated ear	10.4 (8.7)
Quiet, electronic alone 3 months	29.9 (7.9)
Quiet, electronic alone 6 months	31.9 (8.7)
Quiet, electronic alone 12 months	32.8 (7.8)
Quiet, hybrid hearing 3 months	27.4 (9.7)
Quiet, hybrid hearing 6 months	27.0 (11.6)
Quiet, hybrid hearing 12 months	25.3 (8.1)

Primary outcome: Report of Medical/Surgical and Device Related Adverse Events.

Time frame: 12 months post activation.. Number. Unit: Adverse Events

Measure	Implantation With Nucleus CI532 Cochlear Implant n = 12
Possibly procedure related - pinna/behind pain	1
Possibly procedure related - dizziness	2
Possibly procedure related - drop in hearing	1
Possibly procedure related - nausea	1
Possibly procedure related - right ear tinnitus	1
Procedure related - headache	1
Procedure related - incision site pain	1
Procedure related - incision site tenderness	1

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months and 30 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Implantation With Nucleus CI532 Cochlear Implant	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Cochlear do not have an approved platform for sharing IPD. Data may be provided to individual researchers on request.

Related trials for Hearing Loss

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Cowan, DipAud PhD principal investigator

HEARing CRC

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nucleus CI532 cochlear implant in people with Hearing Loss, run by Cochlear at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Report on Degree of Hearing as Measured by Pure Tone Audiogram (time frame: 6 months and 12 months post activation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02671032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.