Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000511639
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
18/05/2023
Date last updated
18/07/2024
Date data sharing statement initially provided
18/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating listening difficulties in children with attention challenges
Scientific title
A randomised controlled trial investigating the use of remote microphone technology to manage listening difficulties in children with attention deficits
Secondary ID [1] 309325 0
25723
Universal Trial Number (UTN)
U1111-1290-3754
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit 329516 0
Listening difficulties 329518 0
Condition category
Condition code
Ear 326452 326452 0 0
Other ear disorders
Mental Health 326453 326453 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a clinical trial evaluating the use of remote microphone technology (RMT) in treating listening (speech perception and listening comprehension) and attention difficulties in normal-hearing children with attention deficits.

The investigational device is the Phonak Roger Touchscreen Microphone paired with Phonak Roger Focus Receivers with SlimTubes and open domes. The receivers are designed for children with normal hearing thresholds, so they provide a safe, comfortable, and adjustable volume for wearers. The receivers are small devices that sit behind each pinna and are held in place by a soft, vented rubber earpiece inserted into the ear canal. They are minimally visible, do not block the ear and allow the wearer access to environmental sound. The Touchscreen Microphone is a compact device, worn by the teacher on a lanyard.

The registration form describes the parent randomised controlled trial (RCT) component of the study. The RCT is a 4-week trial with a 2-period crossover design. Participants will be randomised to one of two treatment sequences:
- 2 weeks of device use followed by 2 weeks of treatment as usual (no device use)
- 2 weeks of treatment as usual (no device use) followed by 2 weeks of device use
During the trial period the children will use the intervention device for 5 days per week for approx 5-6 hours.

Consistent with other clinical trials of RMT, no washout period is included and carryover effects are not anticipated.

Children and teachers will be asked to wear the RMT Monday - Friday for the time the child is in the classroom. To determine the amount of time the device is used, we will ask the teacher to complete a simple compliance check at the conclusion of the device use period

Children and their family will be instructed by a member of the research them and qualified audiologist on how to use the RMT during the first testing session (prior to trial commencement). Instructions will include checking device function, ensuring communication between the microphone and the receiver, changing receiver batteries and how to charge the microphone. Teachers will also be provided the option of a training session conducted by a member of the research team via videoconferencing or a telephone call. Teachers will then assist children in the use of the device in the classroom. Training will occur within 2 weeks prior to the intervention period.
Intervention code [1] 325757 0
Treatment: Devices
Comparator / control treatment
Treatment as usual. For this condition, children will be able to continue to receive interventions for behaviour and learning such as stimulant medication or speech therapy, but will not use the RMT.
Control group
Active

Outcomes
Primary outcome [1] 334297 0
Auditory attention assessed using the Integrated Visual and Auditory-Quick Screen test, in background noise
Timepoint [1] 334297 0
Assessments will be undertaken once at trial baseline and once at trial conclusion by the study audiologist. For this outcome, participants will be randomized into one of two sequences:
- RMT device activated at the baseline visit and deactivated at the trial conclusion visit (4-weeks post-randomisation)
- RMT device deactivated at the baseline visit and activated at the trial conclusion visit (4-weeks post-randomisation)
Primary outcome [2] 334644 0
Visual attention assessed using the Integrated Visual and Auditory-Quick Screen test, in background noise
Timepoint [2] 334644 0
Assessments will be undertaken once at trial baseline and once at trial conclusion by the study audiologist. For this outcome, participants will be randomized into one of two sequences:
- RMT device activated at the baseline visit and deactivated at the trial conclusion visit (4-weeks post-randomisation)
- RMT device deactivated at the baseline visit and activated at the trial conclusion visit (4-weeks post-randomisation)
Secondary outcome [1] 420172 0
Speech perception assessed AZ-Bio Sentences Test in noise
Timepoint [1] 420172 0
Assessments will be undertaken once at trial baseline and once at trial conclusion by the study audiologist. For this outcome, participants will be randomized into one of two sequences:
- RMT device activated at the baseline visit and deactivated at the trial conclusion visit (4-weeks post-randomisation)
- RMT device deactivated at the baseline visit and activated at the trial conclusion visit (4-weeks post-randomisation)
Secondary outcome [2] 420173 0
Listening comprehension assessed using the Test of Auditory Processing skills, fourth edition (TAPS-4) listening comprehension subtest in noise
Timepoint [2] 420173 0
Assessments will be undertaken once at trial baseline and once at trial conclusion by the study audiologist. For this outcome, participants will be randomized into one of two sequences:
- RMT device activated at the baseline visit and deactivated at the trial conclusion visit (4-weeks post-randomisation)
- RMT device deactivated at the baseline visit and activated at the trial conclusion visit (4-weeks post-randomisation)
Secondary outcome [3] 420174 0
Classroom listening (child perspective) assessed using the Listening Inventory for Education - Revised Student Appraisal questionnaire (LIFE-R) (child version)
Timepoint [3] 420174 0
Baseline, end of treatment period 1 (2 weeks post-randomization), end of treatment period 2 (4-weeks post-randomization)
Secondary outcome [4] 420175 0
Classroom listening (teacher perspective) assessed using the Listening Inventory for Education - Revised Student Appraisal questionnaire (LIFE-R) (teacher version)
Timepoint [4] 420175 0
Baseline, end of treatment period 1 (2 weeks post-randomization), end of treatment period 2 (4-weeks post-randomization)
Secondary outcome [5] 420176 0
Inattentive symptoms (parent perspective) assessed using the Conners Parent Short Form - third edition
Timepoint [5] 420176 0
Baseline, end of treatment period 1 (2 weeks post-randomization), end of treatment period 2 (4-weeks post-randomization)
Secondary outcome [6] 420177 0
Inattentive symptoms (teacher perspective) assessed Conners Teacher Short Form - third edition
Timepoint [6] 420177 0
Baseline, end of treatment period 1 (2 weeks post-randomization), end of treatment period 2 (4-weeks post-randomization)

Eligibility
Key inclusion criteria
- Aged 6-12 years
- Normal hearing and middle ear function
- Presenting concerns of listening difficulties
- Evidence of attention deficits - either a diagnosis of ADHD* and/or scoring outside normal limits on a behavioural assessment of auditory and visual attention (conducted routinely at initial auditory processing assessment)
- Participant and at least one caregiver have sufficient English to complete study outcomes, understand and comply with study requirements and to communicate any adverse effects.
- Has a legally acceptable parent/guardian capable of understanding the informed consent document and providing consent on the participant’s behalf.

*Children with ADHD diagnoses who are taking medication for symptoms will be eligible for the study if the dose they are on is stable for at least 4 weeks prior to commencement of the trial.
Minimum age
6 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- School/teachers unwilling to participate
- Hearing loss or abnormal middle ear function
- Full scale IQ < 70 as measured using the Tests of Non-Verbal Intelligence, forth edition (TONI-4) (conducted routinely at initial auditory processing assessment)
- Starting secondary/high school before the conclusion of the trial
- Planned changes to ADHD medication or dosage during the trial

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)
The first randomisation schedule will be to counterbalance the order in which the participant completes the in-clinic AZ-Bio Sentences test, Test of Auditory Processing skills, fourth edition (TAPS-4) listening comprehension subtest, and Integrated Visual and Auditory Quick Screen assessment at the baseline and trial conclusion assessments.

The second randomisation schedule will be to determine the order of conditions for the in-school trial: device followed by treatment as usual, or treatment as usual followed by device.

Randomisation sequences will only be provided to the site audiologist who will conduct the testing. Allocation concealment will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequences will be generated using a sealed envelope web-based randomisation tool:
Sealed Envelope Ltd. 2022. Create a blocked randomisation list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 23 Feb 2023].
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using Minitab software. Paired t-tests will be used to compare within-child changes on the behavioural measures. Repeated-measures analysis of variance will be used to explore the effect of device use on questionnaire outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/03/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24409 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 39988 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 313520 0
University
Name [1] 313520 0
University of Melbourne
Country [1] 313520 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
The University of Melbourne
Grattan Street, Parkville,
Victoria, 3010, Australia
Country
Australia
Secondary sponsor category [1] 315299 0
None
Name [1] 315299 0
N/A
Address [1] 315299 0
N/A
Country [1] 315299 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312707 0
The University of Melbourne Office of Research and Ethics Integrity
Ethics committee address [1] 312707 0
Ethics committee country [1] 312707 0
Australia
Date submitted for ethics approval [1] 312707 0
30/11/2022
Approval date [1] 312707 0
17/02/2023
Ethics approval number [1] 312707 0
2023-23322-36815-4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125626 0
Prof Gary Rance
Address 125626 0
University of Melbourne, Department of Audiology.
550 Swanston Street, Carlton, VIC, 3053
Country 125626 0
Australia
Phone 125626 0
+61 3 9035 5342
Fax 125626 0
Email 125626 0
[email protected]
Contact person for public queries
Name 125627 0
Lucy Shiels
Address 125627 0
University of Melbourne, Department of Audiology.
550 Swanston Street, Carlton, VIC, 3053
Country 125627 0
Australia
Phone 125627 0
+61 3 8344 8167
Fax 125627 0
Email 125627 0
[email protected]
Contact person for scientific queries
Name 125628 0
Lucy Shiels
Address 125628 0
University of Melbourne, Department of Audiology.
550 Swanston Street, Carlton, VIC, 3053
Country 125628 0
Australia
Phone 125628 0
+61 3 8344 8167
Fax 125628 0
Email 125628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning no less than 6 months following main results publications. No end date determined.
Available to whom?
Case-by-case basis at the discretion of the study PI. Researchers must be from a recognised research institute whose proposed use of the data has been ethically reviewed an approved by an independent committee and who accept the Sponsors conditions of access.
Available for what types of analyses?
To achieve aims approved by the PI.
How or where can data be obtained?
Access subject to approvals by the Sponsor and PI.
Principal Investigator contact: [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.