Treating listening difficulties in children with attention challenges

INTERVENTION: 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 appro X5‐6 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 CONDITION: Attention deficit;Listening difficulties; ; Attention deficit ; Listening difficulties Ear ‐ Other ear disorders Mental Health ‐ Learning disabilities PRIMARY OUTCOME: Auditory attention assessed using the Integrated Visual and Auditory‐Quick Screen test, in background noise[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)] Visual attention assessed using the Integrated Visual and Auditory‐Quick Screen test, in background noise[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: Classroom listening (child perspective) assessed using the Listening Inventory for Education ‐ Revised Student Appraisal questionnaire (LIFE‐R) (child version)[Baseline, end of treatment period 1 (2 weeks post‐randomization), end of treatment period 2 (4‐weeks post‐randomization)] Classroom listening (teacher perspective) assessed using the Listening Inventory for Education ‐ Revised Student Appraisal questionnaire (LIFE‐R) (teacher version)[Baseline, end of treatment period 1 (2 weeks post‐randomization), end of treatment period 2 (4‐weeks post‐randomization)] Inattentive symptoms (parent perspective) assessed using the Conners Parent Short Form ‐ third edition[Baseline, end of treatment period 1 (2 weeks post‐randomization), end of treatment period 2 (4‐weeks post‐randomization)] Inattentive symptoms (teacher perspective) assessed Conners Teacher Short Form ‐ third edition[Baseline, end of treatment period 1 (2 weeks post‐randomization), end of treatment period 2 (4‐weeks post‐randomization)] Listening comprehension assessed using the Test of Auditory Processing skills, fourth edition (TAPS‐4) listening comprehension subtest in noise[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)] Speech perception assessed AZ‐Bio Sentences Test in noise[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)] 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.