RecruitingPHASE3INTERVENTIONAL

Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies

This research is looking into how effective a new smartphone app, called Oto, is at helping adults who experience tinnitus. We're comparing it to the talking therapies currently offered by the NHS, like Tinnitus Retraining Therapy (TRT). The main goal is to see if using the app can reduce the impact of tinnitus, improve sleep, and enhance overall quality of life. If you have tinnitus, you might know how it can affect your daily life. This study will ask participants to complete three different questionnaires at the start, then after one, three, and six months. This will help the researchers understand how well each approach works in real-world situations for people living with tinnitus.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

East and North Hertfordshire NHS Trust

Enrolment target

160

Start

20 Jun 2024

Estimated completion

20 Jun 2025

Tinnitus

What is this study about?

This study is a research project designed to explore how a new smartphone app called Oto can help people manage their tinnitus. Tinnitus is when you hear sounds that aren't coming from an outside source, like buzzing, ringing, or whistling. These sounds can be bothersome and affect your daily life, sleep, and general well-being.

We're comparing the Oto app to the talking therapies, such as Tinnitus Retraining Therapy (TRT), that are already available through the NHS. These therapies are designed to help you learn ways to cope with your tinnitus. The researchers want to find out if the Oto app offers a similar or better way to help people reduce how much tinnitus affects them, sleep better, and improve their overall quality of life.

This is an important study because it could help improve how tinnitus is treated in the future. By comparing these two approaches, we hope to gain a clearer understanding of what works best for different people. Your participation would help us gather valuable information to potentially offer more options to people living with tinnitus.

Key takeaways

Compares a smartphone app (Oto) with standard talking therapies for tinnitus.
Aims to improve tinnitus impact, sleep, and quality of life.
Participation involves answering questionnaires over six months.
Open to adults (18+) with tinnitus for at least three months.
You need access to and willingness to use a suitable smartphone if assigned to the app group.

Who may be eligible?

To join this study, you need to be an adult (18 years or older) and be experiencing tinnitus that has lasted for at least three months. Your tinnitus should not be caused by another underlying health problem that's been identified by a scan, and you shouldn't be currently receiving other treatments for your tinnitus, though past treatments like CBT are fine. You also need to be someone who would normally be offered Tinnitus Retraining Therapy (TRT) by the NHS.

Since this study involves a smartphone app, it's really important that you have access to a smartphone that can run the Oto app and that you are happy to use it. If you don't have a suitable phone or aren't comfortable using apps, this study might not be right for you.

People with 'secondary tinnitus' (tinnitus caused by another medical condition confirmed by a scan like an MRI) or those already using other tinnitus treatments (like hearing aids or implants specifically for tinnitus) would not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had tinnitus for at least the last three months?
Do you have a smartphone you're willing to use for the app?
Would your doctor typically suggest Tinnitus Retraining Therapy (TRT) for you?
Are you not currently receiving any other tinnitus treatments (like specific hearing aids for tinnitus)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to either use the Oto smartphone app or receive standard talking therapies like Tinnitus Retraining Therapy. This is a "single-site" study, meaning all participants will be at the same location for their appointments.

You will be asked to complete three different questionnaires at several points: once at the very start (this is called the 'baseline' meeting), then again after one month, three months, and six months. These questionnaires will ask about how your tinnitus affects you, your sleep, and your overall quality of life. There are no specific medications involved in this study. The total duration of your active participation, including all follow-up questionnaires, will be six months.

Potential risks and benefits

Participating in this study might offer you a chance to try a new therapy for your tinnitus that isn't widely available yet, or receive standard NHS-approved therapy. While there are no major physical risks, you might find the questionnaires or using a new app takes some time and effort. As with any clinical trial, there's no guarantee that the treatment you receive will improve your tinnitus. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

East and North Hertfordshire NHS Trust
Verified postcode
Stevenage, United Kingdom· Recruiting

Common questions

What is tinnitus?

Tinnitus is the experience of hearing sounds like ringing, buzzing, or whistling when there is no external sound source.

What is the Oto smartphone app?

The Oto app is a new smartphone application designed to help people manage and cope with their tinnitus.

What are 'talking therapies' for tinnitus?

Talking therapies like Tinnitus Retraining Therapy (TRT) are counseling-based approaches that help you learn to live with tinnitus and reduce its impact.

Will I have to pay for the app?

The study will provide access to the app for participants; you will not need to pay for it during the trial.

How long will the study last for me?

Your involvement in the study, including all follow-up questionnaires, will last for six months.

How to find out more

Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA

amir.habeeb1@nhs.net +447850592603 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.