Effect of 2-phenylethanol Odor Exposure on Ictal Apneic Episode Occurrence Rate in Patients With Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of ictal episodes
研究概览
简要总结
This study will investigate the potential benefits of rose scent in reducing the risk of Sudden Unexpected Death in Epilepsy (SUDEP) in patients with epilepsy. Participants will engage in their routine inpatient observational EEG monitoring for 24 hours followed by an additional 24 hours of observational EEG monitoring with continuous exposure to rose scent, during which an essential oil diffusor with rose scent will be placed in their hospital room. During these 48 total hours of the study, participants will wear a respiratory monitoring belt across their upper chest to measure their breathing.
Potential risks include distress or discomfort when smelling the rose scent used in the study, a physical reaction to the rose scent, and discomfort or feelings of restrictiveness when wearing the respiratory monitoring belt. The total time commitment of the study is 48 consecutive hours over the course of the participants' inpatient EMU stay, during which there will be no restrictions on daily activities during the standard inpatient EMU admission except that participants must wear their respiratory belt for a majority of this 2-day period.
详细描述
[1.0. Background] Sudden unexpected death in epilepsy (SUDEP) affects 1 in 1000 patients with epilepsy every year.1 SUDEP is thought to occur due to respiratory dysfunction during seizure periods, but the exact mechanism remains unclear. Medical management to treat and prevent SUDEP is thus limited and warrants further investigation.
[2.0. Rationale and Specific Aims] Our aim is to observe seizure activity and respiratory function via EEG and respiratory monitoring belt, respectively, following 24 hours of exposure to rose scent via essential oil diffusor in adult patients with epilepsy who have been admitted to the epilepsy monitoring unit (EMU) for observation without medication changes. We hope to uncover a potential olfactory intervention for SUDEP in adult epilepsy patients that would build a stronger understanding of the pathophysiology behind the condition and help reduce the risk of death due to SUDEP.
[3.0. Animal Studies and Previous Human Studies] Several human studies have uncovered a general connection between olfactory modulation and epilepsy by exposing participants with epilepsy to certain scents and then measuring either the frequency and duration of their seizure activity or their EEG activity following scent exposure. A prior human study conducted by Yilmaz et al. indicated a significant antiepileptic benefit of olfactory modulation using lavender scent in 28 pediatric and adult patients aged 8-65 years with drug-resistant epilepsy.6 Focusing on the relationship between olfactory modulation and SUDEP specifically, the principle investigator of this study, Dr. Nobis, has conducted preliminary animal studies indicating that Dravet Syndrome mouse models, which exhibit spontaneous seizures and high SUDEP rates due to a heterozygous deletion in the scn1a gene (scn1a +/-), demonstrate reduced mortality when exposed to 2-phenylethanol (2PE, the major component of rose scent).
[4.0. Inclusion/Exclusion Criteria]
Inclusion Criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult epilepsy patients over the age of 18
- •Admission to the inpatient epilepsy monitoring unit (EMU) at Vanderbilt University Medical Center (VUMC)
- •Undergoing observational EEG monitoring without treatment involving seizure medication changes or other interventions for at least 48 hours
排除标准
- •Patients under the age of 18
- •Patients receiving EEG monitoring without interventions from baseline for less than 48 hours
- •Patients who are not receiving EEG monitoring as a part of their inpatient admission.
研究组 & 干预措施
Rose scent exposure
Ambient rose scent exposure via aromatherapy diffuser into patient room for 24 hours
干预措施: 2-phenylethanol rose scent (Drug)
结局指标
主要结局
Number of ictal episodes
时间窗: 24 hours
Number of ictal episodes measured via EEG
Number of apneic episodes
时间窗: 24 hours
Number of brief cessations in breathing captured via respiratory belt
次要结局
未报告次要终点
研究者
William P. Nobis
Assistant Professor of Neurology
Vanderbilt University Medical Center