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

Phase 3

Recruiting

• Conditions: Tinnitus

• 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

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