Video Game Hearing Tests for Remote Monitoring of Ototoxicity (VAROT)

May 11, 2023 updated by: Imperial College London

Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aminoglycoside antibiotics are widely used in clinical practice to treat life-threatening infections. However, they are associated with ototoxicity leading to hearing loss, tinnitus and vestibular problems.

Mobile devices such as tablet audiometry have recently been validated as a screening tool for hearing loss in an adult cystic fibrosis cohort demonstrating good sensitivity, specificity and positive predictive value when compared to formal sound booth audiometry (Vijayasingam 2020).

Technology from the BEARS project is being adapted to integrate hearing tests within video games and virtual reality software. This technology (Spatial Speech in Noise virtual reality (SSIN-VR) test) will then be used as a tool to perform hearing tests to see if it can detect ototoxicity in adult patients receiving ototoxic agents. The video game-based virtual reality technology (Spatial Speech in Noise and Localisation (SSIN-Loc Training)) will be used to train and potentially improve spatial hearing. This can be done remotely at the convenience of the patient and aims to be an effective way of monitoring hearing autonomously with high usability.

There are 3 pathways within this study:

Pathway 1 (monitoring ototoxicity) is a pilot study to measure the utility and effectiveness of video game-based virtual reality (SSIN-VR) hearing tests as an effective means to monitor hearing loss in patients receiving ototoxic agents. It will be compared with tablet-based audiometry carried out by non-specialist staff, and formal standard sound-booth extended high-frequency audiometry performed by an audiologist. 30 patients receiving an ototoxic agent, presenting at one of the recruiting centres, will be recruited into this pathway.

Pathway 2 is a prospective observational cohort study which continues to validate the use of tablet-based audiometry compared with formal standard sound-booth extended high-frequency audiometry performed by an audiologist. 80 patients, presenting at one of the recruiting centres, will be prospectively recruited into this pathway.

Pathway 3 is a pilot study which assesses whether audio-training (SSIN-Loc training) with video game-based virtual reality (SSIN-VR) hearing tests can improve spatial hearing perception and speech intelligibility. 30 participants will be recruited into this pathway. They will be randomised to either the intervention group (Arm 1) or the control group (Arm 2). All participants will carry out a baseline video game-based virtual reality hearing (SSIN-VR) test in the first week.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, sw3 6NP
        • Recruiting
        • Guy's & St Thomas' NHS Foundation Trust
        • Contact:
      • Poole, United Kingdom, BH15 2JB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monitoring of ototoxicity
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
Video game hearing tests (as a non-medical device) used to monitor ototoxicity
Other Names:
  • SSIN-VR
  • Spatial Speech in Noise-Virtual Reality
No Intervention: Tablet-based audiometry validation
Further validation of tablet-based audiometry compared to formal sound-booth audiometry.
Experimental: Audio-training - intervention arm
Audio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception.
Other: Audio-training
Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.
Other Names:
  • SSIN-Loc training
  • Spatial Speech in Noise and Localisation Training
No Intervention: Audio-training - control arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
Time Frame: For the 4 months that patient is enrolled
For the 4 months that patient is enrolled

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests.
Time Frame: For the 4 months that patient is enrolled
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.
Time Frame: For the 4 months that patient is enrolled
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.
Time Frame: For the 4 months that patient is enrolled
For the 4 months that patient is enrolled
Logistical regression modelling to determine risk factors for developing hearing loss
Time Frame: For the 4 months that patient is enrolled
For the 4 months that patient is enrolled
Pearsons correlation will be used to identify if demographic variables have an effect on questionnaire results.
Time Frame: For the 4 months that patient is enrolled
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.
Time Frame: For the 4 months that patient is enrolled
Attractiveness, perspicuity, efficiency, dependability, simulation and novelty will be interpreted and scaled from -3 (minimum) to +3 (maximum). Scores above +1 indicate a positive impression and values below -1, a negative impression.
For the 4 months that patient is enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Anand Shah, Imperial College London
  • Study Chair: Francis Drobniewski, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2022

Primary Completion (Anticipated)

September 15, 2023

Study Completion (Anticipated)

September 15, 2023

Study Registration Dates

First Submitted

March 7, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2023

Last Update Submitted That Met QC Criteria

May 11, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21HH7217

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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