Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001145695
Ethics application status
Approved
Date submitted
13/10/2023
Date registered
6/11/2023
Date last updated
6/11/2023
Date data sharing statement initially provided
6/11/2023
Date results information initially provided
6/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multimodal app-delivered tinnitus therapy: A feasibility study
Scientific title
Effectiveness of multimodal app-delivered tinnitus therapy in reducing tinnitus severity in adults with tinnitus : A feasibility study
Secondary ID [1] 310786 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
The current study is a sub-study (feasibility study) of the registered study ACTRN12623001138673.

Health condition
Health condition(s) or problem(s) studied:
Tinnitus 331758 0
Condition category
Condition code
Ear 328506 328506 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a two-arm controlled study aiming to investigate the feasibility of utilising a smartphone app (Oto) in tinnitus management as determined by trial acceptability, deliverability, and effectiveness. Oto is 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).
Participants were alternatively allocated to the two groups based on their order of recruitment, i.e., the first participant was allocated to the Oto user group, the second participant was allocated to the non-user group, and so on.
Intervention code [1] 327193 0
Treatment: Other
Comparator / control treatment
The 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.
Control group
Active

Outcomes
Primary outcome [1] 336327 0
Change in tinnitus severity
Timepoint [1] 336327 0
Baseline and 1-month and 3-months since baseline
Secondary outcome [1] 427853 0
App usability
Timepoint [1] 427853 0
3-months since baseline

Eligibility
Key inclusion criteria
Adults (aged 18 years and over)
Experiencing 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
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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/12/2022
Date of last participant enrolment
Anticipated
Actual
10/03/2023
Date of last data collection
Anticipated
Actual
10/06/2023
Sample size
Target
60
Accrual to date
Final
63
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315018 0
Commercial sector/Industry
Name [1] 315018 0
Oto Health Ltd
Country [1] 315018 0
United Kingdom
Funding source category [2] 315019 0
University
Name [2] 315019 0
Flinders University
Country [2] 315019 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] 317044 0
Individual
Name [1] 317044 0
Professor Raj Shekhawat
Address [1] 317044 0
College of Education, Psychology and Social Work, Level 4, Room 4.14, Education Building, Flinders University, Bedford Park 5042, South Australia
Country [1] 317044 0
Australia
Secondary sponsor category [2] 317045 0
Individual
Name [2] 317045 0
Dr Jameel Muzaffar
Address [2] 317045 0
Oto Health Ltd, 45 4th Floor, Silverstream House, 45 Fitzroy Street, London, England, W1T 6EB
Country [2] 317045 0
United Kingdom
Secondary sponsor category [3] 317046 0
Individual
Name [3] 317046 0
Associate Professor Niranjan Bidargaddi
Address [3] 317046 0
College of Medicine and Public Health, Level 2, Room 2.09, Tonsley Main Assembly Building, Flinders University, Tonsley 5042, South Australia
Country [3] 317046 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313987 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 313987 0
Registry Building, Basement, Flinders University, Bedford Park SA 5042
Ethics committee country [1] 313987 0
Australia
Date submitted for ethics approval [1] 313987 0
12/08/2022
Approval date [1] 313987 0
20/09/2022
Ethics approval number [1] 313987 0
5612

Summary
Brief summary
This study aims to investigate the feasibility of utilising a smartphone app (Oto) in tinnitus management as determined by trial acceptability, deliverability, and effectiveness. 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. We hypothesise that the utilisation of Oto in tinnitus management is feasible and deliverable. This study will also test the hypothesis that the use of Oto will significantly reduce tinnitus severity compared to receiving no tinnitus intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130034 0
Mr Boaz Mui
Address 130034 0
College of Psychology, Education and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country 130034 0
Australia
Phone 130034 0
+61 402096877
Fax 130034 0
Email 130034 0
boaz.mui@flinders.edu.au
Contact person for public queries
Name 130035 0
Mr Boaz Mui
Address 130035 0
College of Psychology, Education and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country 130035 0
Australia
Phone 130035 0
+61 402096877
Fax 130035 0
Email 130035 0
boaz.mui@flinders.edu.au
Contact person for scientific queries
Name 130036 0
Mr Boaz Mui
Address 130036 0
College of Psychology, Education and Social Work, Education Building, Flinders University, Bedford Park 5042, South Australia
Country 130036 0
Australia
Phone 130036 0
+61 402096877
Fax 130036 0
Email 130036 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.