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

Primary Purpose

Aminoglycoside Toxicity, Aminoglycoside-Induced Hearing Loss, Hearing Loss

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
video game hearing tests
Audio-training
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aminoglycoside Toxicity

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Guy's & St Thomas' NHS Foundation TrustRecruiting
  • University Hospitals Dorset NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Monitoring of ototoxicity

Tablet-based audiometry validation

Audio-training - intervention arm

Audio-training - control arm

Arm Description

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

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Analysis of spatial speech in noise scores from video game-based virtual reality hearing tests.
Interclass correlation coefficient (ICC) with a 95% confidence interval will be used as a measure of reliability.
Sensitivity, specificity and negative predictive value will be analysed to determine utility of video game-based virtual reality and tablet-based audiometry.
Logistical regression modelling to determine risk factors for developing hearing loss
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.
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.
Pearsons correlation will be used to identify if demographic variables have an effect on questionnaire results.

Full Information

First Posted
March 7, 2023
Last Updated
May 11, 2023
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT05847556
Brief Title
Video Game Hearing Tests for Remote Monitoring of Ototoxicity
Acronym
VAROT
Official Title
Development and Validation of the Use of Video Games and Virtual Reality to Enable Autonomous Remote Monitoring of OTotoxicity in High-risk Population Groups.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aminoglycoside Toxicity, Aminoglycoside-Induced Hearing Loss, Hearing Loss, Video Games

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Monitoring of ototoxicity
Arm Type
Experimental
Arm Description
Video game hearing tests will be used to determine if they can effectively monitor changes in hearing function over time remotely.
Arm Title
Tablet-based audiometry validation
Arm Type
No Intervention
Arm Description
Further validation of tablet-based audiometry compared to formal sound-booth audiometry.
Arm Title
Audio-training - intervention arm
Arm Type
Experimental
Arm Description
Audio-training with video game hearing tests will be used to determine if it can improve spatial hearing perception.
Arm Title
Audio-training - control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
video game hearing tests
Other Intervention Name(s)
SSIN-VR, Spatial Speech in Noise-Virtual Reality
Intervention Description
Video game hearing tests (as a non-medical device) used to monitor ototoxicity
Intervention Type
Other
Intervention Name(s)
Audio-training
Other Intervention Name(s)
SSIN-Loc training, Spatial Speech in Noise and Localisation Training
Intervention Description
Audio-training (as a non-medical device) used to determine if it can improve spatial hearing perception.
Primary Outcome Measure Information:
Title
Pure-tone thresholds analysed through tablet-based audiometry and standard extended high-frequency audiometry.
Time Frame
For the 4 months that patient is enrolled
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Logistical regression modelling to determine risk factors for developing hearing loss
Time Frame
For the 4 months that patient is enrolled
Title
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.
Description
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.
Time Frame
For the 4 months that patient is enrolled
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Cheong
Phone
+442073528121
Email
j.cheong@rbht.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Shah
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Drobniewski
Organizational Affiliation
Imperial College London
Official's Role
Study Chair
Facility Information:
Facility Name
Guy's & St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
sw3 6NP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Cheong
Phone
+442073528121
Email
j.cheong@rbht.nhs.uk
Facility Name
University Hospitals Dorset NHS Foundation Trust
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma King
Email
emmabarker@doctors.org.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
32409613
Citation
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.
Results Reference
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Video Game Hearing Tests for Remote Monitoring of Ototoxicity

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