At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Oto Smartphone Application (Oto Health Ltd) (device), Tinnitus Retraining Therapy (TRT) (behavioural)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- Oto Smartphone Application (Oto Health Ltd) — device: 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. · Tinnitus Retraining Therapy (TRT) — behavioural: Tinnitus-retraining therapy will be offered in the control arm which represents the standard evidence-based intervention on the NHS.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 160
- Started
- 2024-06-20
- Last checked
- 2024-10
Plain English Summary
What is this study?
- • Testing a new treatment for tinnitus
- • Phase3 - 160 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with tinnitus
Where?
- • Stevenage - East and North Hertfordshire NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This 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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Adult patients (male or female) aged over 18 years of age presenting to NHS ENT and hearing services with primary...
- ✓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 agreement to take part.
- ✓Those that would be offered tinnitus retraining therapy (TRT) as management for their primary tinnitus
Who cannot take part
- ✗Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).
- ✗Patients undergoing any other tinnitus therapies concurrently (including hearing aids / implants). Previous tinnitus...
- ✗Patients who are not willing to use the app due to not having a suitable phone to download the application or due to...
See the full criteria
Where Is This Study? (1 UK site)
East and North Hertfordshire NHS Trust
Stevenage SG14AB, United Kingdom
How to Get in Touch
Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA
Sponsor contactCONTACT