Understanding the Role of Band-pass Filtered Familiar Music Stimuli for Use in the Assessment of Hearing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Binaural Sound-field Hearing Threshold Concordance (BPF-FMS vs. Warble Tones)
研究概览
简要总结
Hearing tests are crucial for a child's development, but the standard test, Visual Reinforcement Audiometry (VRA), often doesn't work for those with social communication disorders (SCD) and autism spectrum disorder (ASD). A standardised filtering tool has been developed. Understanding how the results from this new music test compare to standard test results, particularly in people with hearing loss, is critical to establishing the fundamental psychoacoustic threshold relationship. This basic science research validates the acoustic methodology before any future clinical diagnostic application can be considered
详细描述
BACKGROUND AND SCIENTIFIC RATIONALE:
Visual Reinforcement Audiometry (VRA) is the standard behavioral hearing assessment for children with a developmental age of 6 months to 2.5 years, achieving successful threshold determination in up to 92% of neurotypical children. However, testing success drops to approximately 50% in children with Social Communication Disorders (SCD) and Autism Spectrum Disorder (ASD). Incomplete assessments delay the identification and management of permanent hearing loss, impairing speech and language development. To improve test compliance, clinicians frequently present familiar music stimuli (FMS) in the sound-field. Some services apply manual band-pass filtering (BPF) to these music files to isolate discrete octave bands. However, current practice relies on time-consuming, non-standardized off-the-shelf audio editing tools, leading to high acoustic variability across centers. Crucially, the relationship between BPF-FMS behavioral response thresholds and gold-standard puretone/ warble-tone audiometric thresholds remains unknown in listeners with hearing loss, preventing clinicians from accurately plotting music responses onto standard diagnostic audiograms. This non-interventional basic science study utilizes a novel prototype software interface developed by Audio3 Ltd to deliver standardized, octave-band filtering of familiar music stimuli. The project evaluates the fundamental psychoacoustic threshold relationship between BPF-FMS, narrow-band noise (NBN), and goldstandard warble tones in listeners with confirmed permanent hearing loss.
STUDY STRUCTURE AND EXPERIMENTAL DESIGN:
The project operates across seven work-packages (WPs):
- WP1 (Management): Governance and steering committee oversight across the 17-month study lifecycle.
- WP2 (Filtering Strategy & Acoustic Verification): In situ free-field calibration and acoustic verification (complying with BS EN ISO 8253-1 across soundproof booths at Guy's and St Thomas' NHS Foundation Trust (GSTT) and CHEAR Ltd.
- WP3 (Clinical Setup): Finalization of research protocols, ethical approvals, and data management architecture.
- WP4 (Initial Data Collection - Phase 1): Comparative behavioral soundfield testing in 50 participants with confirmed permanent bilateral hearing loss (35 children/teenagers at GSTT; 15 participants at CHEAR Ltd).
- WP5 (Analysis & Optimization): Statistical modeling (Bland-Altman analysis and Linear Mixed-Effects Models) to evaluate threshold agreement between BPF-FMS and warble tones. The filtering parameters (bandwidth, slope, time-windows) are refined based on Phase 1 data.
- WP6 (Review Data Collection - Phase 2): Repeat testing protocol using the optimized BPF-FMS filtering strategy in an independent cohort of 50 participants (35 at GSTT; 15 at CHEAR Ltd).
- WP7 (Final Analysis & Dissemination): Final synthesis, reporting, and deposition of anonymized datasets to open science repositories.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 7 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 7 to 45 years old
- •Able to reliably perform conventional Pure Tone Audiometry
- •Confirmed stable bilateral hearing loss with a 4-frequency (500, 1000, 2000, 4000 Hz) pure-tone average ≥25 dB HL in the better hearing ear
排除标准
- •Aged under 7 or over 45 years old
- •Unable to complete reliable conventional audiometry task mechanics
- •Satisfactory hearing or purely unilateral hearing loss (4-frequency pure-tone average in better ear <25 dB HL)
- •Fluctuating or unconfirmed hearing threshold variations
- •History of Auditory Processing Disorder (APD)
- •History of Auditory Neuropathy Spectrum Disorder (ANSD)
研究组 & 干预措施
Phase 1 Cohort (Initial Filtering Strategy)
50 participants (35 recruited at GSTT and 15 at CHEAR Ltd) with confirmed stable permanent bilateral hearing loss, evaluated using the initial baseline band-pass filtered familiar music stimuli (BPF-FMS) strategy (Work-Package 4)
干预措施: Soundfield Behavioral Audiometry (Other)
Phase 2 Cohort (Optimized Filtering Strategy)
50 independent participants (35 recruited at GSTT and 15 at CHEAR Ltd) with confirmed stable permanent bilateral hearing loss, evaluated using the updated/optimized band-pass filtered familiar music stimuli (BPF-FMS) strategy refined following Phase 1 analysis (Work-Package 6
干预措施: Soundfield Behavioral Audiometry (Other)
结局指标
主要结局
Binaural Sound-field Hearing Threshold Concordance (BPF-FMS vs. Warble Tones)
时间窗: At time of testing (Single 15-minute appointment session)
Quantified threshold agreement between band-pass filtered familiar music stimuli and gold-standard warble tones assessed via mean bias, 95% limits of agreement, and the proportion of matching observations falling within ±5 dB and ±10 dB targets
次要结局
- Absolute Threshold Discrepancy Compared to Narrow-Band Noise(At time of testing (Single 15-minute appointment session))