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临床试验/NCT06386523
NCT06386523已完成不适用

Standardization of a New Psychophysical Olfactory Test, TODA2

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2024年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Passage of olfactory tests:

研究概览

简要总结

Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder:

Interview and clinical examination and Passing the 2 olfactory tests for 30 voluntary's patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st

详细描述

Recruitment of patients consulting the IUFC for another pathology unrelated to an olfactory disorder (otosclerosis, pre- surgery, tonsillectomy, cosmetic surgery)

Data collection methods: 2 parts (duration approximately 1.5 hours) and for 30 volunteer patients, a second consultation of 15 minutes including the time of the test within 7 days after the 1st:

  1. Interview and clinical examination
  2. Passage of olfactory tests: TODA2 and Sniffin Stick Test in unirhinal
  3. On a voluntary basis, and within a limit of 30 patients, those who agree to come back a second time will be able to benefit from a second pass of the TODA2 on Day 7.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects > 18 years old
  • No olfactory complaints; subjective estimation of "normal" olfaction
  • Affiliated to the Social Security system
  • Signing of informed consent

排除标准

  • Parosmia/phantosmia, hyposmia/anosmia, pre-existing subjective dysgeusia/ageusia
  • ATCD of sinus or cranial neoplasia
  • ATCD of sinus or cranial radiotherapy
  • Neurological or neurodegenerative disease
  • ATCD of persistent post-viral hyposmia or anosmia (including COVID) (more than 3 months)

结局指标

主要结局

Passage of olfactory tests:

时间窗: Day 7

TODA2

次要结局

  • Identify confounding factors, i.e. factors that can influence the results of the olfactory test(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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