Trial Outcomes & Findings for CHANGE Feasibility Study (NCT NCT02671032)
NCT ID: NCT02671032
Last Updated: 2021-06-09
Results Overview
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
12 participants
Primary outcome timeframe
6 months and 12 months post activation
Results posted on
2021-06-09
Participant Flow
Participant milestones
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 Participants
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Age, Continuous
|
63 years
n=12 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=12 Participants
|
|
Region of Enrollment
Australia
|
12 participants
n=12 Participants
|
|
Average Initial Age of Hearing Aid Fitted
|
45 years
n=12 Participants
|
|
Onset of Initial Hearing Loss
|
37 years
n=12 Participants
|
|
Severe Hearing Loss
|
3 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: 6 months and 12 months post activationunaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Outcome measures
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 Participants
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6 months, 250 Hz : Function <= 70 dB HL
|
5 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6 months, 250 Hz : Preserved 70 > dB HL <= 90
|
2 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6 months, 250 Hz : Preserved > 90 dB HL
|
2 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6 months, 500 Hz : Function <= 70 dB HL
|
0 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6 months, 500 Hz : Preserved 70 > dB HL <= 90
|
4 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6 months, 500 Hz : Preserved > 90 dB HL
|
4 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6months, 750 Hz : Function <= 70 dB HL
|
0 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6months, 750 Hz : Preserved 70 > dB HL <= 90
|
4 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
6months, 750 Hz : Preserved > 90 dB HL
|
2 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 250 Hz : Function <= 70 dB HL
|
4 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 250 Hz : Preserved 70 > dB HL <= 90
|
3 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 250 Hz : Preserved > 90 dB HL
|
2 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 500 Hz : Function <= 70 dB HL
|
0 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 500 Hz : Preserved 70 > dB HL <= 90
|
5 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 500 Hz : Preserved > 90 dB HL
|
3 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 750 Hz : Function <= 70 dB HL
|
0 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 750 Hz : Preserved 70 > dB HL <= 90
|
4 participants
|
|
Report on Degree of Hearing as Measured by Pure Tone Audiogram
12 months - 750 Hz : Preserved > 90 dB HL
|
2 participants
|
PRIMARY outcome
Timeframe: 3 months, 6 months and 12 months post activationSpeech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Outcome measures
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 Participants
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Report on Clinical Performance in Quiet and Noise
Baseline quiet, treated ear
|
10.4 percentage of correct words
Standard Deviation 8.7
|
|
Report on Clinical Performance in Quiet and Noise
Quiet, electronic alone 3 months
|
29.9 percentage of correct words
Standard Deviation 7.9
|
|
Report on Clinical Performance in Quiet and Noise
Quiet, electronic alone 6 months
|
31.9 percentage of correct words
Standard Deviation 8.7
|
|
Report on Clinical Performance in Quiet and Noise
Quiet, electronic alone 12 months
|
32.8 percentage of correct words
Standard Deviation 7.8
|
|
Report on Clinical Performance in Quiet and Noise
Quiet, hybrid hearing 3 months
|
27.4 percentage of correct words
Standard Deviation 9.7
|
|
Report on Clinical Performance in Quiet and Noise
Quiet, hybrid hearing 6 months
|
27.0 percentage of correct words
Standard Deviation 11.6
|
|
Report on Clinical Performance in Quiet and Noise
Quiet, hybrid hearing 12 months
|
25.3 percentage of correct words
Standard Deviation 8.1
|
|
Report on Clinical Performance in Quiet and Noise
Noise baseline, untreated ear
|
48.2 percentage of correct words
Standard Deviation 36.8
|
|
Report on Clinical Performance in Quiet and Noise
Noise baseline, treated ear
|
25.2 percentage of correct words
Standard Deviation 28.3
|
|
Report on Clinical Performance in Quiet and Noise
Noise, electric alone 3 months
|
81.7 percentage of correct words
Standard Deviation 17.2
|
|
Report on Clinical Performance in Quiet and Noise
Noise, electric alone 6 months
|
80.8 percentage of correct words
Standard Deviation 23.2
|
|
Report on Clinical Performance in Quiet and Noise
Noise, electric alone 12 months
|
85.1 percentage of correct words
Standard Deviation 14.8
|
|
Report on Clinical Performance in Quiet and Noise
Noise, hydrid hearing 3 months
|
77.5 percentage of correct words
Standard Deviation 18.8
|
|
Report on Clinical Performance in Quiet and Noise
Noise, hybrid hearing 6 months
|
72.0 percentage of correct words
Standard Deviation 29.3
|
|
Report on Clinical Performance in Quiet and Noise
Noise, hybrid hearing 12 months
|
83.7 percentage of correct words
Standard Deviation 10.8
|
|
Report on Clinical Performance in Quiet and Noise
Quiet baseline, untreated ear
|
22 percentage of correct words
Standard Deviation 15.4
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 Participants
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly procedure related - pinna/behind pain
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly procedure related - dizziness
|
2 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly procedure related - drop in hearing
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly procedure related - nausea
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly procedure related - right ear tinnitus
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Procedure related - headache
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Procedure related - incision site pain
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Procedure related - incision site tenderness
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Procedure related - jaw ache
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Procedure related - initial insertion tip foldover
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly device related - pinna/behind pain
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly device related - dizziness
|
2 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly device related - drop in hearing
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Possibly device related - nausea
|
1 Adverse Events
|
|
Report of Medical/Surgical and Device Related Adverse Events.
Device related - initial insertion top foldover
|
1 Adverse Events
|
SECONDARY outcome
Timeframe: Preoperative and 6 months post activationEffect 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.
Outcome measures
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 Participants
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Baseline - Speech Hearing
|
4.2 score on a scale
Standard Deviation 2.3
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Baseline - Spatial Hearing
|
3.9 score on a scale
Standard Deviation 2.1
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Baseline - Qualities of Hearing
|
4.7 score on a scale
Standard Deviation 2.3
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Baseline - Overall SSQ
|
4.3 score on a scale
Standard Deviation 2.1
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
6 Month - Speech Hearing
|
5.9 score on a scale
Standard Deviation 2.6
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
6 Month - Spatial Hearing
|
5.4 score on a scale
Standard Deviation 2.7
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
6 Month - Qualities of Hearing
|
6.5 score on a scale
Standard Deviation 2.4
|
|
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
6 Month - Overall SSQ
|
6.0 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: 6 months post activationEffect 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.
Outcome measures
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 Participants
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Glasgow Benefit Inventory (GBI).
General Benefit
|
66.7 score on a scale
Interval 0.0 to 100.0
|
|
Glasgow Benefit Inventory (GBI).
Social Benefit
|
43.1 score on a scale
Interval 0.0 to 100.0
|
|
Glasgow Benefit Inventory (GBI).
Physical Benefit
|
15.3 score on a scale
Interval 0.0 to 100.0
|
|
Glasgow Benefit Inventory (GBI).
Average Benefit
|
54 score on a scale
Interval 0.0 to 100.0
|
Adverse Events
Implantation With Nucleus CI532 Cochlear Implant
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Implantation With Nucleus CI532 Cochlear Implant
n=12 participants at risk
All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant
|
|---|---|
|
Ear and labyrinth disorders
Discomfort/Pain of Pinna and Behind
|
16.7%
2/12 • Number of events 2 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Onset of tinnitus in right ear
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Dizziness
|
25.0%
3/12 • Number of events 3 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Drop in hearing
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Nausea
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cold-like symptoms including sinus congestion
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Headache
|
16.7%
2/12 • Number of events 2 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Jaw ache
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Incision site pain
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Incision site tenderness
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Ear and labyrinth disorders
Otitis Externa
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Nervous system disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Infections and infestations
Abscess in left breast
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Immune system disorders
Polymyalgia Rheumatica
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Infections and infestations
Arm infection
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Injury, poisoning and procedural complications
Cactus injury to wrist
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Musculoskeletal and connective tissue disorders
Hip pain left and right sides
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Musculoskeletal and connective tissue disorders
Pain in body joints
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
|
Skin and subcutaneous tissue disorders
Sun spot removal (actinic keratosis)
|
8.3%
1/12 • Number of events 1 • 12 months and 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place