Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000773033
Ethics application status
Approved
Date submitted
14/09/2010
Date registered
16/09/2010
Date last updated
15/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Prescription Procedures for Cochlear Hybrid Devices in Hearing Loss.
Scientific title
Prescription Procedures for Cochlear Hybrid Devices to optimise the acoustic-to electric output requirements for adults who use a Hybrid device.
Secondary ID [1] 252578 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing loss 258065 0
Condition category
Condition code
Ear 258226 258226 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Many people with severe to profound, high-frequency hearing losses obtain limited benefit from hearing aids, but are not candidates for cochlear implants. Fitting an Electric Acoustic Stimulation (EAS) device, also known as a Hybrid device, may be a useful treatment option because these devices combine a hearing aid and a cochlear implant in the same ear. They allow low-frequency information to be delivered via the hearing aid part, and high-frequency information be delivered via the cochlear implant part. As this technology becomes commercially available and the number of recipients increases, an understanding of how to best apply it is crucial.
Adults who use a Cochlear Hybrid System will be fitted with new hearing aids using standard clinical procedures. These devices will be optimised according to the individual's needs. The performance of these optimised devices will be compared with proprietary device settings using a range of tests including: speech perception, music perception, localisation and functional performance in real life. The overall duration in which the hearing aids will be worn will be six months. The findings will be used as the basis to develop a prescription for devices that combine electric and acoustic stimulation (EAS).
Intervention code [1] 257097 0
Rehabilitation
Intervention code [2] 257098 0
Treatment: Devices
Comparator / control treatment
This study will use a repeated-measures, single-subject design. Each subject serves as his/her own control, thereby accommodating the heterogeneity that characterizes hearing-impaired populations. Such designs are widely used in the study of cochlear implants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259085 0
Relative acoustic-to-electric output requirements for adults who use a Hybrid device.
Outcome assessments: Adults' performance with the optimised devices will be compared with their performance with the proprietary device settings using a range of tests including: speech perception, music perception and localisation testing. In addition, adults will be asked to complete questionnaires in regards to how well the devices perform in real life.
Timepoint [1] 259085 0
These evaluations will be made at baseline and at 12 weeks after the fitting and optimisation of the hearing aids.
Primary outcome [2] 259086 0
Acoustic-to-electric frequency boundary requirements by adults who use a Hybrid device.
Outcome assessments: Adults' performance with three different frequency boundary programs in their Hybrid sound processor will be evaluated using a range of tests including: speech perception, music perception, localisation testing and functional performance in real life questionnaires.
Timepoint [2] 259086 0
These evaluations will be made at baseline and at 4 and 8 weeks after randomisations of frequency boundary allocation programs.
Secondary outcome [1] 265377 0
Basis for deriving a theoretical prescription procedure for the fitting of devices that combine electric and acoustic stimulation.
Timepoint [1] 265377 0
At completion of study the acoustic-to-electric frequency boundary allocation and output levels findings will be analysed and used as the basis to develop a prescription for fitting devices that combine electric and acoustic stimulation (EAS).

Eligibility
Key inclusion criteria
1. Will be eighteen years of age or older at the time of evaluation.
2. Will be users of a Cochlear Hybrid System with a minimum of 12 months experience prior to enrolment.
3. The audiometric criteria for residual hearing in the implanted ear will be within the range of normal to profound.
4. A willingness to wear all device conditions (New hearing aids and Hybrid sound processor) on a daily basis for the duration of the study.
5. A willingness to participate in and to comply with all requirements of the protocol including a willingness to complete all tests and questionnaires.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Children under the age of 18 years of age.
2. People whose primary language is other than English (LOTEs).
3. Additional needs or disability that would prevent participation in evaluations.
4. Unrealistic expectations on the part of the participant, regarding the possible benefits and limitations of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3157 0
2067
Recruitment postcode(s) [2] 3158 0
3010
Recruitment postcode(s) [3] 3159 0
1675
Recruitment postcode(s) [4] 3216 0
2067

Funding & Sponsors
Funding source category [1] 257548 0
Other Collaborative groups
Name [1] 257548 0
The HEARing Cooperative Research Centre Limited
Country [1] 257548 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The HEARing Cooperative Research Centre Limited
Address
550 Swanson Street
Audiology, Hearing and Speech Sciences
The University of Melbourne VICTORIA 3010
Country
Australia
Secondary sponsor category [1] 256769 0
Government body
Name [1] 256769 0
National Acoustic Laboratories
Address [1] 256769 0
126 Greville Street
Chatswood NSW 2067
Country [1] 256769 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259573 0
Australian Hearing Human Research Ethics Committee (EC00109)
Ethics committee address [1] 259573 0
126 Greville Street
Chatswood NSW 2067
Ethics committee country [1] 259573 0
Australia
Date submitted for ethics approval [1] 259573 0
15/07/2010
Approval date [1] 259573 0
03/09/2010
Ethics approval number [1] 259573 0
Approval Number AHHREC2010-4

Summary
Brief summary
Many people with severe to profound, high-frequency sensorineural (permanent) hearing losses obtain minimal benefit from hearing aids, but do not meet the criteria for standard cochlear implantation. An Electric Acoustic Stimulation (EAS) device, also known as a Hybrid device, combines acoustic amplification in the low frequencies where hearing can be effectively aided, with electric stimulation in the high frequencies where hearing loss is profound, all within one implantable system. Fitting an Electric Acoustic Stimulation (EAS) device may be an effective treatment option for people with severe to profound high frequency hearing losses. As this technology becomes commercially available and the number of recipients increases, an understanding of how to best fit and combine the acoustic and electric stimulation to maximise outcomes for recipients is crucial.
Although a significant amount of EAS research has been conducted over the last 10 years, the main focus of reported work has been on the post-operative hearing preservation outcomes and perceptual benefits of this intervention. To date the approach to fitting these devices has been highly variable and no systematic attempts have been made to optimise the fitting for maximising outcomes for recipients.
The main aims of the proposed study are: 1. To optimise EAS devices as implemented in the Cochlear Hybrid System, which consists of a Nucleus Hybrid L24 cochlear implant and a Hybrid sound processor. 2.To evaluate the effect of systematic variations of acoustic to electrical stimulation on speech perception, music perception, localisation and functional performance in real life. The findings will be used as the basis to develop a prescription for devices that combine electric and acoustic stimulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31577 0
Address 31577 0
Country 31577 0
Phone 31577 0
Fax 31577 0
Email 31577 0
Contact person for public queries
Name 14824 0
Paola Incerti
Address 14824 0
Senior Research Audiologist
National Acoustic Laboratories
126 Greville Street
Chatswood NSW 2067.
Country 14824 0
Australia
Phone 14824 0
+61 2 9412 6963
Fax 14824 0
+61 2 9411 8273
Email 14824 0
[email protected]
Contact person for scientific queries
Name 5752 0
Paola Incerti
Address 5752 0
Senior Research Audiologist
National Acoustic Laboratories
126 Greville Street
Chatswood NSW 2067.
Country 5752 0
Australia
Phone 5752 0
+61 2 9412 6963
Fax 5752 0
+61 2 9411 8273
Email 5752 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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