The DEFINE Trial - Digital Therapy For Improved Tinnitus Care

Tinnitus therapy, including Cognitive Behavioural Therapy (CBT) is an effective treatment for helping people to manage tinnitus. This study aims to compare the effectiveness of a new digital tinnitus therapy, The Oto Tinnitus Programme, to conventional tinnitus therapy.

The Oto Tinnitus Programme is a digital approach to tinnitus management that delivers therapies through a self-paced smartphone app.

The DEFINE study will randomly assign adults with tinnitus to receive the Oto programme or therapist-delivered conventional tinnitus therapy, evaluating both their effectiveness in reducing tinnitus severity as well as the financial implications of both approaches.

Participants will be required to complete electronic surveys throughout the 12-month study period while receiving therapy for their tinnitus. You will be compensated £40 for your time.

Click here to take part

Haga clic aquí para participar

Teilnehmen

Klik hier om deel te nemen

Study for

Estudio dirigido a

Zielgrupper der Studie

Onderzoek voor:

Adults with tinnitus persisting for at least 3 months and severe enough to impact their daily life.

Patrocinado por

Gesponsert von

Opdrachtgever:

Oto Health

Participants

Participantes

Teilnehmenden

Deelnemers:

196

People

Personen

Participate by

Participar mediante

Abschlussdatum

Duur van onderzoek:

December 31, 2023

31.12.2023

What is expected of me?

¿Qué se espera de mí?

Was wird von mir erwartet?

Wat wordt van mij verwacht?

1. First you will fill out a pre-screening questionnaire on this website.

2. If you are eligible based on this questionnaire, you will have a telephone/video call with a trained member of the trial team. During the call, the team member will fully explain the research study and further assess eligibility with some health-related questions, including conducting a short hearing test. They will also be able to answer any questions regarding the study prior to informed consent.

3. If eligible, you will then be randomly assigned to one of the study groups. You will either receive therapist-delivered tinnitus therapy or therapy from the Oto Tinnitus Programme.

4. If you are allocated to the Oto programme, you will need to download and set up the Oto app. If allocated to the standard CBT arm you will be asked to book an appointment with one of the trial therapists.

5. At the start of the study, you will be required to complete baseline assessments.

6. You will be asked to fill out further surveys at 1, 3, 6, and 12 months, which will require you to provide the following information:

Any changes in your tinnitus or symptoms.
A questionnaire about your interactions with healthcare services and any other treatments or expenses related to your tinnitus.
How easy it was for you to use either the smartphone app or video call software, depending on which group you were assigned to.

7. At months 6 and 12, some participants will have the opportunity to take part in a focus group to discuss your experience.

Contact our study team

define@lindushealth.com

What is the benefit for me?

¿En qué me beneficia?

Welchen Nutzen habe ich davon?

Wat is het voordeel voor mij?

All participants will receive £40 for taking part in this research study. This will be split across the full length of the research.
Taking part in this study will allow you to receive treatment for your tinnitus without a significant wait. Typically, individuals with tinnitus will experience delays in treatment, waiting weeks or months. As a participant in the study, you will quickly receive standard care or free access to the Oto app therapies.
Participants have the opportunity to contribute to new and improved treatments for tinnitus in the future.

Who is the study for?

¿A quién va dirigido el estudio?

Für wen ist die Studie geeignet?

Voor wie is het onderzoek bedoeld?

You are aged 18 years or over
You have experienced Tinnitus symptoms for 3 months or longer and you feel the condition is regularly impacting your quality of life
You have access to a smartphone
You are able and willing to give consent for the study prior to participation
You are able to fluently speak and read English