Using a smartphone app to treat tinnitus in adults compared to standard therapies
Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial
This study is testing whether a smartphone app can help adults with tinnitus feel better compared to the usual therapy they receive.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | East and North Hertfordshire NHS Trust Government |
| Locations | 1 site (Stevenage, Hertfordshire) |
| Trial ID | NCT06623123 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Oto smartphone app in treating chronic primary subjective tinnitus in adults, comparing it to the standard tinnitus retraining therapy (TRT) offered by the NHS. Participants will complete three questionnaires at baseline, one month, three months, and six months to assess tinnitus burden, insomnia severity, and quality of life. The study is a single-site randomized controlled trial conducted at East and North Hertfordshire NHS Trust.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with chronic non-pulsatile tinnitus lasting at least three months who are willing to use a smartphone app.
Not a fit: Patients with secondary tinnitus or those currently undergoing other tinnitus therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and effective treatment option for patients suffering from tinnitus.
How similar studies have performed: While there have been studies on tinnitus treatments, the specific use of a smartphone app in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Stevenage, Hertfordshire
- East and North Hertfordshire NHS Trust — Stevenage, Hertfordshire, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Amir Habeeb, MBBS BSc MSc MRCS (ENT) AFHEA
- Email: amir.habeeb1@nhs.net
- Phone: +447850592603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.