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Trial registered on ANZCTR


Registration number
ACTRN12623001138673
Ethics application status
Approved
Date submitted
10/10/2023
Date registered
3/11/2023
Date last updated
3/11/2023
Date data sharing statement initially provided
3/11/2023
Date results information initially provided
3/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of app-delivered tinnitus therapy
Scientific title
Effectiveness of app-delivered therapy in reducing tinnitus severity in adults with tinnitus: A randomised controlled trial
Secondary ID [1] 310772 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 331731 0
Condition category
Condition code
Ear 328478 328478 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled study aiming to evaluate the effectiveness of Oto, a smartphone app developed by Oto Health Ltd., which aims to help people manage their tinnitus and decrease their tinnitus severity. Oto is a novel multimodal app-delivered approach to tinnitus available for iOS and Android. It combines patient education, cognitive behavioural therapy (CBT), relaxation, mindfulness, and sound therapy in a customisable package. In particular, Oto provides a five-week tinnitus habituation program consisting of 60 recorded therapy sessions focusing on topics such as acceptance and commitment therapy (ACT), CBT, relaxation, mindfulness, and visualisation. Oto also offers a total of 116 therapy sessions (including those in the habituation program) that can be listened at the participants' own pace if they wish to explore beyond the habituation program. In general, each therapy session takes approximately 5-10 minutes to complete. Furthermore, Oto provides a sound library consisting of 78 kinds of sounds such as ocean, brown noise, and thunderstorm for masking tinnitus and facilitating sleep. Usage of Oto is self-paced and at the comfort of the participants' own home, though a suggested timescale for the habituation program is provided within the app. The self-paced and self-administered delivery method allows patients to avoid taking time off work, travel time to a hospital, and face-to-face contact with other people if necessary. As the nature of Oto is self-guided, all components of the app are optional based on the participants' needs and interests. However, Oto users were advised at the baseline to follow the suggested timeline for the habituation program as much as they could. No strategy was used to monitor adherence to using Oto, but participants' online written consent was sought to collect app usage data from Oto's end and these data will be de-identified and used for data analysis. Oto has received Medicines and Healthcare products Regulatory Agency (MRHA) certification as a Class 1 medical device in the UK. Participants in the Oto-user group were given cost free access to Oto for nine months (length of study period).
An online focus group consisting of 10-12 Oto users will be organised at 6-months to discuss 1) barriers to seeking and obtaining advice and treatment for tinnitus, 2) participants' ideas, concerns, and expectations about Oto, 3) their interaction with Oto, 4) suggested improvements to the delivery or content of Oto, and 5) how Oto would best be employed within the Hearing Services Program (HSP) or hearing care system. Microsoft Teams will be used to record and transcribe the discussion after participants have provided online written consent. The focus group will be conducted by Boaz Mui, the principal investigator of this trial. Participants will be selected by purposeful sampling based on demographic characteristics (e.g., age, gender, tinnitus duration) to ensure recruitment of participants with different characteristics.
Intervention code [1] 327178 0
Treatment: Other
Comparator / control treatment
The control group was on a wait list during the study period. Participants in the non-user (control) group were instructed not to install Oto and other tinnitus smartphone apps during the study period. It is stated explicitly in the study consent form that individuals will not be able to participate in this study if they are currently undertaking another tinnitus intervention, and all consented participants agreed to this term. Participants in the non-user (control) group will be provided cost free access to Oto for nine months after the completion of this study.
Control group
Active

Outcomes
Primary outcome [1] 336301 0
Change in tinnitus severity
Timepoint [1] 336301 0
Baseline and 1-month, 3-months, 6-months (primary end-point), and 9-months since baseline
Secondary outcome [1] 427765 0
App usability
Timepoint [1] 427765 0
6-months since baseline

Eligibility
Key inclusion criteria
Adults (aged 18 years and over)
Experiencing bilateral non-pulsatile chronic tinnitus (>6 months) at the time of recruitment
Have access to a smartphone device capable of running Oto (iOS or Android version available)
Are willing to use Oto during the study period
Demonstrating at least a lower moderate tinnitus severity on the Tinnitus Functional Index (at least 18 points out of 100 points) at the time of recruitment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have known impairment likely to impact on a participant's ability to participate in research activities
Are currently enrolled in another hearing/tinnitus study
Are currently undertaking another tinnitus intervention
Are awaiting surgical intervention for hearing/tinnitus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation was employed using a blocked randomisation list generated from sealed envelope (https://www.sealedenvelope.com/simple-randomiser/v1/lists). Block sizes were set at 4, 6 and the list length was set for 120 individuals. Stratification factors included age group (65 or below, over 65), gender (male, female), hearing level (normal hearing, mild hearing loss or above), and initial TFI score (less than or equal to 50, greater than 50).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The developers of TFI suggest that at least a 13-point reduction on the TFI indicates a clinically meaningful reduction in tinnitus severity. Assuming that mean difference = 13.0, SD = 18 (from previous pilot study), alpha = 0.05, and power = 0.90, the total estimated sample size is 82. Considering a dropout rate of around 10%, the estimated sample size is 90.
Repeated measures ANOVA will be performed to determine any significant difference in the TFI scores between all timepoints within and between groups. App usability scores collected from MAUQ will be examined by descriptive analysis. Qualitative data collected from the focus group will be analysed by thematic analysis using NVivo.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
3/07/2023
Date of last participant enrolment
Anticipated
Actual
29/09/2023
Date of last data collection
Anticipated
25/06/2024
Actual
Sample size
Target
90
Accrual to date
Final
94
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315002 0
Commercial sector/Industry
Name [1] 315002 0
Oto Health Ltd
Country [1] 315002 0
United Kingdom
Funding source category [2] 315004 0
University
Name [2] 315004 0
Flinders University
Country [2] 315004 0
Australia
Primary sponsor type
Individual
Name
Boaz Mui
Address
College of Education, Psychology and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country
Australia
Secondary sponsor category [1] 317022 0
Individual
Name [1] 317022 0
Professor Raj Shekhawat
Address [1] 317022 0
College of Education, Psychology and Social Work, Level 4, Room 4.14, Education Building, Flinders University, Bedford Park 5042, South Australia
Country [1] 317022 0
Australia
Secondary sponsor category [2] 317024 0
Individual
Name [2] 317024 0
Dr Jameel Muzaffar
Address [2] 317024 0
Oto Health Ltd, 45 4th Floor, Silverstream House, 45 Fitzroy Street, London, England, W1T 6EB
Country [2] 317024 0
United Kingdom
Secondary sponsor category [3] 317025 0
Individual
Name [3] 317025 0
Associate Professor Niranjan Bidargaddi
Address [3] 317025 0
College of Medicine and Public Health, Level 2, Room 2.09, Tonsley Main Assembly Building, Flinders University, Tonsley 5042, South Australia
Country [3] 317025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313974 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313974 0
Registry Building, Basement, Flinders University, Bedford Park SA 5042
Ethics committee country [1] 313974 0
Australia
Date submitted for ethics approval [1] 313974 0
12/08/2022
Approval date [1] 313974 0
20/09/2022
Ethics approval number [1] 313974 0
5612

Summary
Brief summary
This study aims to evaluate the effectiveness and app usability of a smartphone app (Oto) in tinnitus management. Oto is a novel multimodal app-delivered approach to tinnitus available for iOS and Android. It combines patient education, cognitive behavioural therapy (CBT), relaxation, mindfulness, and sound therapy in a customisable package. Oto has received Medicines and Healthcare products Regulatory Agency (MRHA) certification as a Class 1 medical device in the UK. This study will test the hypothesis that the use of Oto will significantly reduce tinnitus severity than receiving no tinnitus intervention (i.e., being on a wait list).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129982 0
Mr Boaz Mui
Address 129982 0
College of Psychology, Education and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country 129982 0
Australia
Phone 129982 0
+61 402096877
Fax 129982 0
Email 129982 0
boaz.mui@flinders.edu.au
Contact person for public queries
Name 129983 0
Mr Boaz Mui
Address 129983 0
College of Psychology, Education and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country 129983 0
Australia
Phone 129983 0
+61 402096877
Fax 129983 0
Email 129983 0
boaz.mui@flinders.edu.au
Contact person for scientific queries
Name 129984 0
Mr Boaz Mui
Address 129984 0
College of Psychology, Education and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country 129984 0
Australia
Phone 129984 0
+61 402096877
Fax 129984 0
Email 129984 0
boaz.mui@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.