None listed
Conditions
Brief summary
Learning disorders are one of the greatest causes of morbidity in children with the genetic syndrome, neurofibromatosis type 1 (NF1) and result in academic underachievement, reduced quality of life, and are of significant concern to families and their teachers. There are minimal evidence-based interventions for these problems in NF1, and there is an urgent need for trials targeting this area of clinical need. The parent TAP-iN study described on this registry consists of a randomised controlled four-week crossover trial conducted in children with NF1 and auditory processing difficulties. The proposed study will enable us to establish the efficacy of remote microphone listening devices in treating central auditory deficits in children with NF1. Outcomes are clinically meaningful and include measures of speech perception and functional hearing ability. If realized, this study will provide powerful evidence for a novel, non-invasive intervention targeting a common and impairing problem in NF1.
Interventions
This is a multisite phase II/III clinical trial evaluating the use of a remote microphone listening (RML) device in treating speech perception in noise difficulties in children with neurofibromatosis type 1 (NF1).
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.
This is a multisite phase II/III clinical trial evaluating the use of a remote microphone listening (RML) device in treating speech perception in noise difficulties in children with neurofibromatosis type 1 (NF1). 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 Consistent with other clinical trials of RML devices, no washout period is included and carryover effects are not anticipated. Children and teachers will be asked to wear the RML device 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 daily compliance check. Children and their family will be instructed on how to use the RML device including checking device function, ensuring communication between the microphone and the receiver, and how to charge the batteries. 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
Murdoch Children's Research Institute
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
• Children aged 6-12 years • Satisfy the revised diagnostic criteria for NF1 • 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 • Demonstrate a functional hearing difficulty on the Listening in Spatialized Noise - Sentences (LiSN-S) test [Note: defined as 1 standard deviation below the normative age range for the Different Voice 90°, Same Voice 90° and/or spatial advantage conditions] • School/teachers willing to participate in the study (of any age)
Exclusion criteria
• School/teachers unwilling to participate • Active ear infection at the time of screening • Evidence of sensory hearing loss (defined by a 4-frequency average hearing loss (average of 0.5-, 1-, 2-, and 4 kHz) of >20dbHL in both ears, or use of corrective hearing device such as a hearing aid or cochlear implant. • Full Scale IQ (FSIQ) <70 on standardised test of intellectual functioning. • Plan to commence or change medication (or dosage) for ADHD symptoms during the 4-week RCT. In these cases, children will be considered eligible if they have been on a stable dose of ADHD medication for 4 weeks prior to screening (and they meet all other eligibility requirements). • Symptomatic or progressive intracranial pathology that may affect scores on audiological, cognitive, or behavioural outcome measures (e.g., acquired brain injury, or hydrocephalus). Asymptomatic or stable low-grade gliomas that are not thought to impact on outcome measures will not result in exclusion.
Outcome results
None listed