跳至主要内容
临床试验/NCT05540561
NCT05540561招募中不适用

Biological Alterations of Laughing Gas Outcomes in Neurology

University Hospital, Lille10 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
356
试验地点
10
主要终点
Blood markers related to nitrous oxide consumption

研究概览

简要总结

There is a toxicity linked to the chronic use of nitrous oxide, leading to neurological disorders such as combined sclerosis of the spinal cord. One thus frequently observes patients presenting disorders of walking or paresthesias, of more or less resolving evolution being able to go until the need for using a wheelchair and more recently cases of thrombosis were reported Serum or urine N2O assays are rarely performed routinely, because they do not allow to ensure a real exposure due to the very short half-life of this gas in the body. Thus, other biological monitoring markers are mentioned in the literature, such as vitamin B12 or homocysteine. Unfortunately, there are still no recommendations for biological monitoring of nitrous oxide consumption. Moreover, underlying mechanisms leading to clinical outcomes remains misunderstood.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A current or former recreational nitrous oxide user defined
  • With associated clinical signs (group 1)
  • Without associated clinical signs (group 2)
  • With or without clinico-biological sequelae associated with use
  • Consenting to the conduct of the study
  • Socially insured

排除标准

  • Pregnant or breastfeeding women
  • Never used nitrous oxide or stopped using it more than 6 months ago
  • Lack of social security coverage
  • Not willing to participate in the entire study

结局指标

主要结局

Blood markers related to nitrous oxide consumption

时间窗: through study completion an average of 1 year

Biomarkers of cobalamin metabolism, methionine cycle and oxidative stress

次要结局

  • The severity of the clinical signs related to nitrous oxide consumption.(Baseline, at 4 weeks,and/or at 3 months and at 6 months)
  • Blood markers related to nitrous oxide clinical outcomes.(Baseline, at 4 weeks, at 3 months and at 6 months)
  • Estimated and self-reported nitrous oxide consumption(Baseline, at 4 weeks,and/or at 3 months and at 6 months)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (10)

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