None listed
Conditions
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.
Interventions
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 v
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.
Sponsors
University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Healthy volunteers
No
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.
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
Outcome results
None listed