Tinnitus Ear, Nose and Throat Tinnitus
Conditions
Interventions
Participants will be randomised using the ‘Sealed Envelope’ randomisation service to one of two arms, intervention or control.
Intervention Group
The Oto Tinnitus Programme is a digital therapeutic c
Sponsors
Oto Health Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Experienced tinnitus symptoms for at least 3 months and self-assessed as having a significant impact on quality of life 3. Have access to a smartphone 4. Able and willing to give consent for the study prior to participation 5. Able to speak and read English to a sufficient level
Exclusion criteria
Exclusion criteria: 1. Tinnitus with potential “red flag” symptoms i.e. unilateral or pulsatile tinnitus (assessed via a red flag checklist during the screening call) 2. Significant mental health problems e.g. history of suicidal ideation or requirement for psychiatric/psychological support beyond primary care level 3. Have required hospitalisation for depression or taking antipsychotic drug 4. Currently taking part in another clinical trial for hearing/tinnitus 5. Awaiting surgical intervention for hearing/tinnitus 6. Previously undergone tinnitus therapy of any type e.g. CBT or TRT 7. Pregnant and breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Self-reported tinnitus severity measured using the Total Tinnitus Functional Index (TFI) score 6 months from starting therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-reported tinnitus severity measured using the total TFI and TFI subscale scores at 1, 3 and 12 months 2. Participant health-related quality of life measured using the EuroQol EQ-5D-5L and the Health Utilities Index Mark 3 (HUI3) responses and summary scores at 3, 6 and 12 months follow-up from starting therapy 3. Adverse events measured using participant-reported side effects or medical events while participating in the DEFINE study from randomisation to 3 months 4. OTO digital app programme usability measured using the System Usability Scale scores at 3 months 5. Qualitative feedback from focus groups and semi-structured interviews at 3, 6 and 12 months 6. Cost-utility analysis synthesising costs and quality-adjusted life years (QALYs) over the trial period 7. Intervention adherence assessed using electronic case report form data at 3 and 6 months | — |
Countries
United Kingdom
Outcome results
None listed