Video Game Hearing Tests for Remote Monitoring of Ototoxicity

NCT05847556 | Unknown

• 1 other identifier: 21HH7217
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

The reason for this clinical trial is to test different ways of carrying out hearing tests to be able to detect for hearing loss within the hospital and at home. Pathway 1: The goal of this clinical trial is to learn whether video game hearing tests work well to detect hearing loss caused by antibiotics at home in patients with long-term lung infections. Pathway 2: The goal of this clinical trial is to compare tablet-based (iPad) hearing tests with formal sound booth hearing tests in patients attending hospital outpatient clinics. Pathway 3: The goal of this clinical trial is to learn whether audio-training improves listening to speech in the presence of background noise. Researchers will compare participants receiving audio-training with those who did not receive audio-training. This will test if audio-training can improve participant's everyday listening experiences.

Conditions

Aminoglycoside Toxicity; Aminoglycoside-Induced Hearing Loss; Hearing Loss; Video Games

Outcome Measures

Primary Outcomes (1)

• Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.

  For the 4 months that patient is enrolled

Secondary Outcomes (6)

• Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests.

  For the 4 months that patient is enrolled

• Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as a measure of reliability.

  For the 4 months that patient is enrolled

• Sensitivity, specificity and negative predictive value will be analysed to determine utility of video game-based virtual reality and tablet-based audiometry.

  For the 4 months that patient is enrolled

• Logistical regression modelling to determine risk factors for developing hearing loss

  For the 4 months that patient is enrolled

• 7-point Likert scale questionnaires will be used to evaluate patient satisfaction of video game-based virtual reality hearing tests, audio-training, tablet-based and formal audiometry.

  For the 4 months that patient is enrolled

Study Arms (4)

Monitoring of ototoxicity

EXPERIMENTAL

Video game hearing tests will be used to determine if they can effectively monitor changes in hearing function over time remotely.

Other: video game hearing tests

Tablet-based audiometry validation

NO INTERVENTION

Further validation of tablet-based audiometry compared to formal sound-booth audiometry.

Audio-training - intervention arm

EXPERIMENTAL

Audio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception.

Other: Audio-training

Audio-training - control arm

NO INTERVENTION

No audio-training but video game hearing tests will be used as a comparator arm to identify if audio-training can improve spatial hearing perception.

Interventions

video game hearing tests OTHER

Video game hearing tests (as a non-medical device) used to monitor ototoxicity

Also known as: SSIN-VR, Spatial Speech in Noise-Virtual Reality

Monitoring of ototoxicity

Audio-training OTHER

Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.

Also known as: SSIN-Loc training, Spatial Speech in Noise and Localisation Training

Audio-training - intervention arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients ≥16 years old intended to receive \>1 day of an ototoxic agent (Pathway 1)
• All patients ≥16 years old (Pathways 2 and 3)
• Able to provide informed consent to participate in study (written and witnessed).

You may not qualify if:

• Inability of patient to provide informed consent.
• Patients with previous diagnosed visual impairment that cannot be corrected with glasses.
• Inability to attend audiology appointments due to state of health.
• Pregnant women.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Guy's & St Thomas' NHS Foundation Trust

London, sw3 6NP, United Kingdom

RECRUITING

University Hospitals Dorset NHS Foundation Trust

Poole, BH15 2JB, United Kingdom

RECRUITING

Related Publications (2)

• Vijayasingam A, Frost E, Wilkins J, Gillen L, Premachandra P, Mclaren K, Gilmartin D, Picinali L, Vidal-Diez A, Borsci S, Ni MZ, Tang WY, Morris-Rosendahl D, Harcourt J, Elston C, Simmonds NJ, Shah A. Tablet and web-based audiometry to screen for hearing loss in adults with cystic fibrosis. Thorax. 2020 Aug;75(8):632-639. doi: 10.1136/thoraxjnl-2019-214177. Epub 2020 May 14.

  PMID: 32409613 BACKGROUND

• Cheong J, Lowe E, Lee CW, Barbosa C, Gillen L, King E, Premachandra P, Shah A, Drobniewski F. Globally applicable solution to hearing loss screening: a diagnostic accuracy study of tablet-based audiometry. BMJ Open. 2025 May 22;15(5):e097550. doi: 10.1136/bmjopen-2024-097550.

  PMID: 40404318 DERIVED

MeSH Terms

Conditions

Hearing Loss

Interventions

Noise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Environmental Pollution; Public Health

Study Officials

• Anand Shah

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Francis Drobniewski

  Imperial College London

  STUDY CHAIR

Central Study Contacts

Jamie Cheong

CONTACT

+442073528121; j.cheong@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pathway 1: pilot study of non-medical device Pathway 2: observational cohort study of medical device Pathway 3: randomised pilot study of non-medical device

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: May 6, 2023
• Study Start: March 16, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Locations

GB (2)