Digital thErapy For Improved tiNnitus carE Study (DEFINE)

Not Applicable

• Conditions: Tinnitus; Ear, Nose and Throat

• Registration Number: ISRCTN99577932
• Lead Sponsor: Oto Health Ltd

Brief Summary

2024 Protocol article in https://doi.org/10.1371/journal.pone.0292562 (added 08/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-21
• Last Update Posted: 22 January 2024
• Study Completion: 2024-06-11

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 196

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified