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

Phase 3

Recruiting

• Conditions: Tinnitus
• Interventions: Behavioral: Tinnitus Retraining Therapy (TRT); Device: Oto Smartphone Application (Oto Health Ltd)

• Registration Number: NCT06623123
• Lead Sponsor: East and North Hertfordshire NHS Trust

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-06-20
• Study First Submitted: 2024-09-30
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-06-20
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tinnitus Retraining Therapy (TRT) Arm	Tinnitus 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.
Oto Smartphone Application	Oto 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.

Primary Outcome Measures

Name	Time	Method
Tinnitus Burden	6 months total post intervention start date	Tinnitus burden via Tinnitus Functional Index questionnaires at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity	6 months total post intervention start date	Insomnia index as calculated via Insomnia Severity Index questionnaire at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).
Quality of Life	6 months total post intervention start date	Quality of life as calculated via the WHO Quality of Life - BREF questionnaire at 0 months (T0), 1 month (T1), 3 months (T2) and 6 months (T3).

Trial Locations

Locations (1)

East and North Hertfordshire NHS Trust; 🇬🇧 Stevenage, Hertfordshire, United Kingdom