Vaping-Related Seizures - A Prospective Case-Crossover Study
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
- 否
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
Peter.S.Tatum
Epilepsy Fellow
Dartmouth-Hitchcock Medical Center
