Treating auditory problems in children with neurofibromatosis type 1: extension trial

Not Applicable

Recruiting

• Conditions: eurofibromatosis type 1; Neurofibromatosis type 1; Neurological - Other neurological disorders; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Ear - Other ear disorders

• Registration Number: ACTRN12622001329752
• Lead Sponsor: Murdoch Children's Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-14
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children aged 6-12 years.
• Satisfy the revised diagnostic criteria for NF1.
• Consented to and screened for the parent RCT trial.
• 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.
• School/teacher willing to participate in the study (of any age).

Exclusion Criteria

• School/teachers unwilling to participate.
• Consent and screening not undertaken for the parent RCT.
• 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.
• Starting secondary school/high school within 9 months of commencing this extension phase of the study
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified