RecruitingPhase 3NCT06623123

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

Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial

Sponsor

East and North Hertfordshire NHS Trust

Enrollment

160 participants

Start Date

Jun 20, 2024

Study Type

INTERVENTIONAL

Conditions

Tinnitus

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This randomized controlled study compares the Oto smartphone app — a digital tool using cognitive behavioral therapy (CBT) principles — against tinnitus retraining therapy (TRT, an established NHS talking therapy) for adults living with chronic primary tinnitus, a persistent ringing or buzzing in the ears not caused by an identifiable underlying condition. The study measures tinnitus-related distress, sleep quality, and overall quality of life using validated questionnaires at baseline, 1 month, 3 months, and 6 months. Adults over 18 with primary non-pulsatile tinnitus lasting at least 3 months, who own a compatible smartphone, and who would typically be offered TRT through NHS ENT services are eligible; those with secondary tinnitus confirmed by MRI or who are already using hearing aids or other tinnitus therapies are excluded. Participation involves being randomly assigned to the app or TRT and completing questionnaires at regular intervals. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEOto Smartphone Application (Oto Health Ltd)

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.

BEHAVIORALTinnitus Retraining Therapy (TRT)

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.