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Recruiting Phase 3 NCT06623123

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

Trial Parameters

Condition Tinnitus
Sponsor East and North Hertfordshire NHS Trust
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 160
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-06-20
Completion 2025-06-20
Interventions
Oto Smartphone Application (Oto Health Ltd)Tinnitus Retraining Therapy (TRT)

Brief 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 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.

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