ISRCTN99577932进行中(未招募)Unknown
Digital thErapy For Improved tiNnitus carE Study (DEFINE)
Oto Health Ltd0 个研究点目标入组 196 人开始时间: 2023年7月21日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 196
研究概览
简要总结
2024 Protocol article in https://doi.org/10.1371/journal.pone.0292562 (added 08/01/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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