跳至主要内容
临床试验/ISRCTN99577932
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

发起方
Oto Health Ltd

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