A randomised controlled trial to determine the effect of remote microphone listening devices on speech perception and functional hearing in children with neurofibromatosis type 1 and auditory deficits

Murdoch Children's Research Institute0 个研究点目标入组 124 人开始时间: 2022年10月14日最近更新: 2023年5月8日

适应症

试验速览

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•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 2 standard deviations 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)

•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.

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