From Early Music Audiometry to Tone Audiograms

NCT07722936 | Not Yet Recruiting

• 1 other identifier: IRAS: 351560
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Hearing Loss; Audiometric Tests

Keywords

Music Audiometry; Psychoacoustics; Visual Reinforcement Audiometry; Band-Pass Filtered Stimuli; Paediatric Audiology

Outcome Measures

Primary Outcomes (1)

• Binaural Sound-field Hearing Threshold Concordance (BPF-FMS vs. Warble Tones)

  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

  At time of testing (Single 15-minute appointment session)

Secondary Outcomes (1)

• Absolute Threshold Discrepancy Compared to Narrow-Band Noise

  At time of testing (Single 15-minute appointment session)

Other Outcomes (1)

• Acoustic Signal Recognition Threshold Offset

  At time of testing (Single 15-minute appointment session)

Study Arms (2)

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)

Other: Soundfield Behavioral Audiometry

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

Other: Soundfield Behavioral Audiometry

Interventions

Soundfield Behavioral Audiometry OTHER

Single 15-minute behavioral soundfield hearing detection task comparing conventional warble tones, narrow-band noise, and band-pass filtered familiar music stimuli (BPF-FMS). Group 1 receives BPF-FMS generated via the baseline filtering algorithm; Group 2 receives BPF-FMS generated via the optimized filtering algorithm

Phase 1 Cohort (Initial Filtering Strategy); Phase 2 Cohort (Optimized Filtering Strategy)

Eligibility Criteria

• Age: 7 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, teenagers, and adults aged 7 to 45 years with confirmed, stable, permanent bilateral hearing loss (4-frequency pure-tone average ≥25 dB HL in the better hearing ear) who are able to reliably perform pure-tone audiometry. Participants are sampled from the active clinical caseloads at Guy's and St Thomas' NHS Foundation Trust (GSTT) Paediatric Audiology service and CHEAR Ltd.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• London South Bank University: collaborator
• Audio3 Ltd: collaborator
• CHEAR Ltd: collaborator

Study Sites (2)

Guy's and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

CHEARLtd

Royston, SG8 6QS, United Kingdom

Location

Related Publications (4)

• Young, J., 2020. A review of the use of children's television theme tunes as soundfield stimuli in services. BAA Magazine, pp. 18-19

  BACKGROUND

• Widen JE, Johnson JL, White KR, Gravel JS, Vohr BR, James M, Kennalley T, Maxon AB, Spivak L, Sullivan-Mahoney M, Weirather Y, Meyer S. A multisite study to examine the efficacy of the otoacoustic emission/automated auditory brainstem response newborn hearing screening protocol: results of visual reinforcement audiometry. Am J Audiol. 2005 Dec;14(2):S200-16. doi: 10.1044/1059-0889(2005/022).

  PMID: 16489864 BACKGROUND

• BSA, 2024. Recommended Procedure: Visual Reinforcement Audiometry. British Society of Audiology

  BACKGROUND

• BSA, 2018. Recommended Procedure: Pure-tone air-conduction and bone-conduction threshold audiometry with and without masking. British Society of Audiology.

  BACKGROUND

Related Links

• Professional Practice Guidelines

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Keiran D Joseph, MSc

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keiran D Joseph, MSc

CONTACT

07929615170; keiran.joseph@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become publicly available on the OSF repository within 12 months of study completion and will remain accessible indefinitely.
• Access Criteria: Unrestricted open access via the Open Science Framework (OSF) public repository.

Locations

GB (2)