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Trial registered on ANZCTR


Registration number
ACTRN12623000512628
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
18/05/2023
Date last updated
16/06/2024
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: extension trial
Scientific title
An extension trial to determine the effect of remote microphone technology to manage listening difficulties in children with attention deficits
Secondary ID [1] 309210 0
25723 (extension)
Universal Trial Number (UTN)
U1111-1290-3683
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit 329517 0
Listening difficulties 329519 0
Condition category
Condition code
Ear 326451 326451 0 0
Other ear disorders
Mental Health 326454 326454 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 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.

Children enrolled in this trial will have consented for participation in the parent study, which is a shorter randomised controlled trial (RCT) of RMT. Duration of the randomised controlled trial is 2 school weeks wearing the device (5 days per week for approx 5-6 hours) and 2 weeks treatment as usual in the school classroom. After completing participation in the parent study, participants will be invited into this extension trial where they will wear the RMT for a longer period of time. Duration of the extended trial is 30 school weeks wearing the device (5 days per week for approx 5-6 hours). This will enable us to determine whether longer-term device use can improve auditory processing, cognitive skills, literacy, attention and listening outcomes for children with attention deficits.

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 every 3 weeks during the device use period.

There are several pathways a child can take to participate in this extension trial. All of them will require informed consent of the parent RCT. Children with attention deficits can participate in this extension trial via the following pathways:

1. Children with attention deficits who are eligible to complete the parent RCT and following completion of that trial, they opt to continue wearing the RMT device in the classroom for an additional 30 school weeks. In this case, they will be enrolled in the treated condition of the extension trial.

2. Children with attention deficits who are eligible to complete the parent RCT and following completion of that trial, they opt to not continue wearing the RMT device in the classroom. In this case, they will be invited into the treatment as usual control condition of the extension trial.

3. Children with attention deficits who are eligible to complete the parent RCT but are not interested in participating in any device trial. In this case, they will be invited into the treatment as usual control condition of the extension trial.

For children in the treated condition, they will be asked to wear the RMT device Monday to 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 every 3 weeks so we can determine the amount of time the device was used.
Intervention code [1] 325759 0
Treatment: Devices
Comparator / control treatment
Treatment as usual. Children in the treatment as usual control condition children will be able to continue to receive interventions for behaviour and learning such as stimulant medication or speech therapy, but will not wear the RMT device.
Control group
Active

Outcomes
Primary outcome [1] 334299 0
Auditory attention assessed using the Integrated visual and auditory quick screen continuous performance task (IVA-QS)
Timepoint [1] 334299 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
Primary outcome [2] 334645 0
Visual attention assessed using the Integrated visual and auditory quick screen continuous performance task (IVA-QS)
Timepoint [2] 334645 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
Secondary outcome [1] 420180 0
Binaural integration assessed using the Dichotic digits difference test (DDdT)*
Timepoint [1] 420180 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
*For participants aged 7+ only
Secondary outcome [2] 420181 0
Binaural interaction assessed using the Listening in spatialized noise - sentences (LiSN-S)
Timepoint [2] 420181 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
Secondary outcome [3] 420182 0
Temporal sequencing assessed using the Frequency pattern test (FPT)*
Timepoint [3] 420182 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
*For participants aged 7+ only
Secondary outcome [4] 420183 0
Temporal processing assessed using the Gaps in noise test (GIN)*
Timepoint [4] 420183 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
*For participants aged 7+ only
Secondary outcome [5] 420184 0
Auditory working memory assessed using the Test of Auditory Processing skills, fourth edition (TAPS-4) numbers forward and numbers reversed subtests (this will be assessed as a composite outcome)
Timepoint [5] 420184 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
Secondary outcome [6] 420185 0
Reading fluency assessed using the Wheldall Assessment of Reading Passages (WARP)*
Timepoint [6] 420185 0
Trial extension baseline and conclusion (30 school weeks post-baseline).
*For participants aged 7+ only
Secondary outcome [7] 420186 0
Classroom listening assessed using the Listening Inventory for Education - Revised Student Appraisal questionnaire (LIFE-R) (child version)
Timepoint [7] 420186 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [8] 420187 0
Inattentive symptoms assessed using the Conners Teacher Short Form - third edition
Timepoint [8] 420187 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [9] 420188 0
Quality of life assessed using the Pediatric Quality of Life Generic Scales (PedsQL) (parent version)
Timepoint [9] 420188 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [10] 420189 0
Listening difficulties assessed using the Evaluation of Children's Listening and Processing Skills (ECLiPS)
Timepoint [10] 420189 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [11] 420190 0
Anxiety assessed using the Behavior Assessment System of Children - third edition (BASC-3) (child version)**
Timepoint [11] 420190 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
**For participants aged 8+ only
Secondary outcome [12] 421969 0
Classroom listening assessed using the Listening Inventory for Education - Revised Student Appraisal questionnaire (LIFE-R) (teacher version)
Timepoint [12] 421969 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [13] 421970 0
Inattentive symptoms assessed using the Conners Parent Short Form - third edition
Timepoint [13] 421970 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [14] 421971 0
Quality of life assessed using the Pediatric Quality of Life Generic Scales (PedsQL) (child version)
Timepoint [14] 421971 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [15] 421972 0
Anxiety assessed using the Behavior Assessment System of Children - third edition (BASC-3) (teacher version)
Timepoint [15] 421972 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)
Secondary outcome [16] 421973 0
Anxiety assessed using the Behavior Assessment System of Children - third edition (BASC-3) (parent version)
Timepoint [16] 421973 0
Trial extension baseline, half-way (approx 15 school weeks post-baseline) and trial extension conclusion (approx 30 school weeks post-baseline)

Eligibility
Key inclusion criteria
- Participants must have consented to participation in, and completed, the parent RCT trial
- 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.
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
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using Minitab software. Repeated measures analysis of variance will be used to evaluate the impact of long-term device use on behavioural and questionnaire measures between groups (control vs experimental).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/04/2023
Date of last participant enrolment
Anticipated
31/05/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
50
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24411 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 39992 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 313398 0
University
Name [1] 313398 0
University of Melbourne
Country [1] 313398 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] 315165 0
None
Name [1] 315165 0
N/A
Address [1] 315165 0
N/A
Country [1] 315165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312617 0
The University of Melbourne Office of Research and Ethics Integrity
Ethics committee address [1] 312617 0
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010, Australia
Ethics committee country [1] 312617 0
Australia
Date submitted for ethics approval [1] 312617 0
30/11/2022
Approval date [1] 312617 0
17/02/2023
Ethics approval number [1] 312617 0
2023-23322-36815-4

Summary
Brief summary
Children with listening difficulties (LiD) have normal sound detection but disproportionate difficulty processing speech, particularly in noisy environments. LiD may be as a consequence of auditory processing, cognitive or language deficits. Clinically, it is challenging to delineate the possible causes of symptoms in individuals, however attention is one cognitive area known to impact listening ability in a large proportion of these children.

Remote microphone technology (RMT) improves signal accessibility by transmitting a speaker's voice (via a microphone worn on a lanyard) directly to ear-level receivers worn by the child. These devices are commonly trialled in children with LiD, but the possible assistive benefits for those exhibiting attention deficits have not thoroughly been explored. The current study will investigate the efficacy of remote microphone technology (Phonak Roger Touchscreen Microphone paired with Phonak Roger Focus II receivers) to improve functional listening and cognitive abilities, classroom behaviour and quality of life in children with attention deficits.

Based on previous literature, it is hypothesized that 30 weeks of RMT device use will improve classroom behaviour, quality of life, listening and attention skills in children with attention deficits.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125298 0
Prof Gary Rance
Address 125298 0
University of Melbourne, Department of Audiology.
550 Swanston Street, Carlton, VIC, 3053
Country 125298 0
Australia
Phone 125298 0
+61 3 9035 5342
Fax 125298 0
Email 125298 0
[email protected]
Contact person for public queries
Name 125299 0
Lucy Shiels
Address 125299 0
University of Melbourne, Department of Audiology.
550 Swanston Street, Carlton, VIC, 3053
Country 125299 0
Australia
Phone 125299 0
+61 3 8344 8167
Fax 125299 0
Email 125299 0
[email protected]
Contact person for scientific queries
Name 125300 0
Lucy Shiels
Address 125300 0
University of Melbourne, Department of Audiology.
550 Swanston Street, Carlton, VIC, 3053
Country 125300 0
Australia
Phone 125300 0
+61 3 8344 8167
Fax 125300 0
Email 125300 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

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