Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies
October 1, 2024 updated by: Amir Habeeb, East and North Hertfordshire NHS Trust
Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial
A study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service.
Three separate questionnaires will be used to collect this data from patients at regular time intervals.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Single-site randomised controlled study looking at tinnitus burden, insomnia severity and quality of life in adults with chronic primary subjective tinnitus when using Oto smartphone app compared with National Institute for Health and Care Excellence (NICE) approved tinnitus retraining therapy.
This will be assessed objectively through questionnaires at the baseline meeting, one month, three months and six months.
Study Type
Interventional
Enrollment (Estimated)
160
Phase
- Phase 3
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
- Name: Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA
- Phone Number: +447850592603
- Email: amir.habeeb1@nhs.net
Study Locations
-
-
Hertfordshire
-
Stevenage, Hertfordshire, United Kingdom, SG14AB
- Recruiting
- East and North Hertfordshire NHS Trust
-
Contact:
- Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA
- Phone Number: +447850592603
- Email: amir.habeeb1@nhs.net
-
Contact:
- Ananth Vijendren, BM FRCS (ORL-HNS) PhD
-
Contact:
- Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patients (male or female) aged over 18 years of age presenting to NHS ENT and hearing services with primary non-pulsatile tinnitus irrespective of hearing.
- Patients must be suffering from tinnitus for a minimum of 3 months
- Patients that have a willingness to use as well as have access to a smartphone device capable of running Oto.
- Willing and able to provide written informed consent.
- Those that would be offered tinnitus retraining therapy (TRT) as management for their primary tinnitus
Exclusion Criteria:
- Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).
- Patients undergoing any other tinnitus therapies concurrently (including hearing aids / implants). Previous tinnitus therapies including CBT in the past are accepted.
- Patients who are not willing to use the app due to not having a suitable phone to download the application or due to own limitations in working Oto.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Tinnitus Retraining Therapy (TRT) Arm
Tinnitus-retraining therapy will be offered in the control arm which represents the standard evidence-based intervention on the NHS.
(2) Participants enrolled to this arm will undertake tinnitus retraining therapy with a trained audiologist.
The sessions will last 30 minutes with the option for further sessions should the patient which to have more support with their tinnitus to mimic the NHS programme as much as possible.
These sessions will encompass a brief audiological history followed by therapy tailored to the patient's needs allowing for patient-centred optimisation of tinnitus burden and secondary comorbidities.
This may include relaxation, CBT and advice surrounding sound as well as white noise masking therapy.
|
Tinnitus-retraining therapy will be offered in the control arm which represents the standard evidence-based intervention on the NHS.
(2) Participants enrolled to this arm will undertake tinnitus retraining therapy with a trained audiologist.
The sessions will last 30 minutes with the option for further sessions should the patient which to have more support with their tinnitus to mimic the NHS programme as much as possible.
These sessions will encompass a brief audiological history followed by therapy tailored to the patient's needs allowing for patient-centred optimisation of tinnitus burden and secondary comorbidities.
This may include relaxation, CBT and advice surrounding sound as well as white noise masking therapy.
|
|
Experimental: Oto Smartphone Application
The smartphone application delivers personalized tinnitus therapy combining evidence-based CBT with mindfulness, patient education as well as physical therapy such as stretches and exercises.
There are additional sounds available to listen to from the sound library.
There will be a structured programme that the participants can work through however they are encouraged to personalise their own therapy.
|
The smartphone application delivers personalized tinnitus therapy combining evidence-based CBT with mindfulness, patient education as well as physical therapy such as stretches and exercises.
There are additional sounds available to listen to from the sound library.
There will be a structured programme that the participants can work through however they are encouraged to personalise their own therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tinnitus Burden
Time Frame: 6 months total post intervention start date
|
Tinnitus burden via Tinnitus Functional Index questionnaires at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).
|
6 months total post intervention start date
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insomnia Severity
Time Frame: 6 months total post intervention start date
|
Insomnia index as calculated via Insomnia Severity Index questionnaire at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).
|
6 months total post intervention start date
|
|
Quality of Life
Time Frame: 6 months total post intervention start date
|
Quality of life as calculated via the WHO Quality of Life - BREF questionnaire at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).
|
6 months total post intervention start date
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
- Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
- Shargorodsky J, Curhan GC, Farwell WR. Prevalence and characteristics of tinnitus among US adults. Am J Med. 2010 Aug;123(8):711-8. doi: 10.1016/j.amjmed.2010.02.015.
- Vahedi S. World Health Organization Quality-of-Life Scale (WHOQOL-BREF): Analyses of Their Item Response Theory Properties Based on the Graded Responses Model. Iran J Psychiatry. 2010 Fall;5(4):140-53.
- Carlbring P, Andersson G, Cuijpers P, Riper H, Hedman-Lagerlof E. Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: an updated systematic review and meta-analysis. Cogn Behav Ther. 2018 Jan;47(1):1-18. doi: 10.1080/16506073.2017.1401115. Epub 2017 Dec 7.
- Mehdi M, Dode A, Pryss R, Schlee W, Reichert M, Hauck FJ. Contemporary Review of Smartphone Apps for Tinnitus Management and Treatment. Brain Sci. 2020 Nov 17;10(11):867. doi: 10.3390/brainsci10110867.
- Lewis S, Chowdhury E, Stockdale D, Kennedy V; Guideline Committee. Assessment and management of tinnitus: summary of NICE guidance. BMJ. 2020 Mar 31;368:m976. doi: 10.1136/bmj.m976. No abstract available.
Helpful Links
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)
June 20, 2024
Primary Completion (Estimated)
June 20, 2025
Study Completion (Estimated)
June 20, 2025
Study Registration Dates
First Submitted
September 30, 2024
First Submitted That Met QC Criteria
October 1, 2024
First Posted (Actual)
October 2, 2024
Study Record Updates
Last Update Posted (Actual)
October 2, 2024
Last Update Submitted That Met QC Criteria
October 1, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD2023-05 OTO
- Corporate Funding (Other Identifier: Oto Health Ltd)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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.