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临床试验/NCT06006442
NCT06006442撤回不适用

Vaping-Related Seizures - A Prospective Case-Crossover Study

Dartmouth-Hitchcock Medical Center1 个研究点 分布在 1 个国家开始时间: 2023年9月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Odds of Vaping Related Seizure

研究概览

简要总结

This case-crossover study evaluates the association between vaping and seizures in patients of a large academic medical center who admits to vaping and hav a planned ambulatory EEG ordered.

详细描述

This case-crossover study will evaluate the short-term effects (seizures) of intermittent exposure to vaping nicotine and/or marijuana products among Dartmouth Hitchcock Medical Center (DHMC) patients aged 21 years or older who already have planned ambulatory EEG study ordered and admit to vaping. The duration of data collection will vary (24-72 hours) depending on ambulatory EEG length was ordered.

Inclusion criteria includes any DHMC patient who admits to vaping and has a planned ambulatory EEG of any duration, regardless of diagnosis or reason for study. Exclusion criteria will include subjectively admitting to using any illicit drugs other than cannabinoids since within 7 days of the study and/or anyone who denies smoking since it would be an ethical issue having someone smoke for the first time during a research study.

All subjects will sign a DHMC and IRB approved consent form to participate in the study before it starts. They will receive one copy and another copy will be kept by DHMC in the patient chart. An optional survey/questionnaire will be obtained before the study to confirm if the patient vapes, what products and doses they use, and what other medications or drugs they use. Personal information will also be obtained for later stratification, including age, sex, sexuality, household income, race, ethnicity, heritage, culture, education level, medical history, psychiatric history.

During the study, subjects will keep a vaping diary for 24 to 72 hours depending on how long their study was ordered for. All patients will document the dates, times, contents, brands, sources, doses, and durations of use in their vaping diary which will be handed to the research team at the end of the study.

Each patient will serve as their own control by assessing EEG for seizures and interictal discharges at different times as follows:

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria includes any DHMC patient who admits to vaping and has a planned ambulatory EEG of any duration, regardless of diagnosis or reason for study.

排除标准

  • Exclusion criteria will include subjectively admitting to using any illicit drugs other than cannabinoids since within 7 days of the study and/or anyone who denies smoking since it would be an ethical issue having someone smoke for the first time during a research study.

结局指标

主要结局

Odds of Vaping Related Seizure

时间窗: The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping

Odds ratio of vaping during periods of seizures versus periods of seizure freedom.

次要结局

  • Odds of Increased Interictal Discharges After Vaping(The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter.S.Tatum

Epilepsy Fellow

Dartmouth-Hitchcock Medical Center

研究点 (1)

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