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Trial registered on ANZCTR


Registration number
ACTRN12615000651583
Ethics application status
Approved
Date submitted
14/05/2015
Date registered
24/06/2015
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Date results information initially provided
9/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Children with Unilateral Hearing Loss (CUHL) study: Does early hearing device fitting improve language and psychosocial outcomes?
Scientific title
Does early hearing device fitting improve language and psychosocial outcomes of children with congenital hearing loss in one ear?
Secondary ID [1] 286184 0
None
Universal Trial Number (UTN)
U1111-1225-0607
Trial acronym
CUHL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss 294213 0
Condition category
Condition code
Ear 294530 294530 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Despite early detection of congenital Unilateral Hearing Loss (UHL) via universal newborn hearing screening (UNHS), there is a lack of evidence on the efficacy of early intervention (in the form of device fitting) for improving outcomes, and the benefit vs harms of early detection and treatment is uncertain. This study will follow children from diagnosis to 3 years of age to investigate the impact of UHL, and examine the benefit (if any) of device fitting.

By agreeing to participate, a child with a unilateral hearing impairment would be allocated to one of two groups, 1) a device ‘fitting’ group , or 2) a ‘no fitting’ group. By participating in the study, all families and their children will be offered a study-specific program of support commensurate with best practice. Parents will be asked to complete a consent form before being informed as to which group their child has been allocated.

For children assigned to the ‘fitting’ group, each child’s Australian Hearing (AH) clinician will choose a device in consultation with the child’s parents, and fit the device in accordance with standard procedures.

All families in both groups will be offered a support program that involves intensive monitoring through tympanometry every 3 months. If a child consistently exhibits middle ear disorders in the good ear for longer than 6 months, the child will be referred to AH for review (and potential fitting), irrespective of experimental assignment. Standard audiometry will be offered annually, around the time of outcomes assessments. Significant changes in hearing thresholds will be referred to AH audiologists.

In addition, all parents will be provided with a starter kit that contains information on childhood unilateral hearing loss, child development, communication strategies and activities on how to help the child, and where to get further support if needed. All families will also be offered access to information sessions to be organised by parent-support groups throughout the duration of the study.
Intervention code [1] 291197 0
Treatment: Devices
Comparator / control treatment
The comparator group will be children with UHL who are not fitted with a device.
Control group
Active

Outcomes
Primary outcome [1] 294308 0
The primary outcome is language ability, measured using parent report at 1 and 2 yrs (OZI - Australian version of MacArthur-Bates Communication Inventory) and direct administration of the Preschool Language Scale (PLS), Diagnostic Evaluation of Articulation and Phonology (DEAP) and Peabody Picture Vocabulary Test (PPVT) at 3 yrs.
Timepoint [1] 294308 0
Evaluations will be made when the child is 1, 2 and 3 years of age.
Secondary outcome [1] 313004 0
The secondary outcome is functional evaluation in real-world environments, measured using the Parents' Evaluation of Aural/oral performance of Children (PEACH); and language input the child receives in the home environment by audio-recording using a LENA device.
Timepoint [1] 313004 0
Evaluations will be made when the child is 1, 2 and 3 years of age.

Eligibility
Key inclusion criteria
Children born between May 2014 and June 2017 in NSW, VIC and QLD who were diagnosed as having a permanent unilateral hearing loss via UNHS.
Minimum age
0 Months
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of bilateral hearing loss

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Once consent is provided from the child's parent/guardian, he/she will be assigned by the researchers to one of two rehabilitation groups:

Group 1. An AH audiologist will work with the family to select the most appropriate hearing device for the child.

Group 2. Children in this group will NOT be fitted with a hearing device at the commencement of the project. However, if audiological changes are noted (as part of the study’s monitoring program), the research team will work with AH to ensure the parent/guardian and child receive the necessary assistance. This may include fitting a device if required.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants will be carried out via randomised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
A variation to the research protocol of group assignment will be needed if a statistically and clinically significant group difference is found in the measures of early language outcomes. If this occurs, we will terminate the experimental allocation and ensure that all children in the study receive the intervention that is linked to better outcomes.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
According to the Queensland Government 2012-2013 Healthy Hearing Data Report, approximately 0.6 per thousand infants who undergo UNHS are diagnosed with UHL per year. Therefore across 3 states of NSW, QLD and VIC it is estimated there will be approximately 150 children diagnosed with UHL per year. If we assume approximately 60% of UHL infants will be recruited into the study over 2 years, this would be a total of 180 participants. The use of multiple linear regressions with 10 predictor variables with a power of 0.8 and type 1 error of .05 suggests a minimum of 118 participants be used to detect a medium effect size. Allowing for the clinical and statistical assumptions, a 10-15% attrition rate, and considerations of feasibility, we adopted a target of 200 participants for this study.

Standard multiple linear regression analysis will be used to examine the relationship between language outcome scores and potential predictor variables (including device fitting, degree of hearing loss, age of fitting, communication mode, maternal speech input (words and conversational turns), maternal education, socio-economic advantage, gender, and other disabilities). Their relation to each other will be assessed with correlation analysis.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 291038 0
Other Collaborative groups
Name [1] 291038 0
The HEARing Cooperative Research Centre Limited
Address [1] 291038 0
550 Swanston Street
Audiology, Hearing and Speech Sciences
The University of Melbourne
Victoria 3010
Country [1] 291038 0
Australia
Funding source category [2] 291261 0
Government body
Name [2] 291261 0
National Institutes of Health (NIH)
Address [2] 291261 0
National Institutes of Health
9000 Rockville Pike
Bethesda, Maryland 20892
Country [2] 291261 0
United States of America
Primary sponsor type
Government body
Name
National Acoustic Laboratories, Australian Hearing
Address
National Acoustic Laboratories,
Australian Hearing Hub
16 University Ave
Macquarie University,
North Ryde
NSW 2109
Country
Australia
Secondary sponsor category [1] 289951 0
Other Collaborative groups
Name [1] 289951 0
The HEARing Cooperative Research Centre Limited
Address [1] 289951 0
550 Swanston Street
Audiology, Hearing and Speech Sciences
The University of Melbourne
Victoria 301
Country [1] 289951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292622 0
Australian Hearing Human Research Ethics Committee (EC00109)
Ethics committee address [1] 292622 0
Level 5, 16 University Avenue
Australian Hearing Hub
Macquarie University,
North Ryde
NSW 2109
Ethics committee country [1] 292622 0
Australia
Date submitted for ethics approval [1] 292622 0
Approval date [1] 292622 0
17/10/2014
Ethics approval number [1] 292622 0
AHHREC2014-28

Summary
Brief summary
Despite early detection of congenital unilateral hearing loss (UHL) via universal newborn hearing screening (UNHS), there is a lack of evidence on the efficacy of early intervention (in the form of device fitting) for improving outcomes, and the benefit vs harms of early detection and treatment is uncertain. Consequently, there is clinical equipoise concerning whether children should receive amplification (as well as surveillance).

The overall goal of this project is to determine the efficacy of device intervention for improving outcomes of children diagnosed with permanent unilateral hearing loss at or shortly after birth. The aims are to: 1) investigate the impact of early detection and treatment of UHL on the child and family; 2) determine factors affecting outcomes at 3 years of age for children with congenital UHL; and 3) assess the efficacy of device fitting on improving outcomes. The results of this research will provide the much-needed evidence-based guidance for clinical practice.
Trial website
http://www.cuhl.nal.gov.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54958 0
Dr Teresa Ching
Address 54958 0
National Acoustic Laboratories
Australian Hearing Hub
Level 5, 16 University Avenue,
Macquarie University,
North Ryde,
NSW 2109
Country 54958 0
Australia
Phone 54958 0
+612 9412 6832
Fax 54958 0
+612 9412 6769
Email 54958 0
teresa.ching@nal.gov.au
Contact person for public queries
Name 54959 0
Ms Patricia Van Buynder
Address 54959 0
National Acoustic Laboratories
1-3 Hall St
Moonee Ponds,
Victoria 3039
Country 54959 0
Australia
Phone 54959 0
+613 8325 9015
Fax 54959 0
Email 54959 0
patricia.vanbuynder@nal.gov.au
Contact person for scientific queries
Name 54960 0
Dr Teresa Ching
Address 54960 0
National Acoustic Laboratories
Australian Hearing Hub
Level 5, 16 University Avenue,
Macquarie University,
North Ryde,
NSW 2109
Country 54960 0
Australia
Phone 54960 0
+612 9412 6832
Fax 54960 0
+612 9412 6769
Email 54960 0
teresa.ching@nal.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
ethics approval did not provide for data sharing
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary