Effect of Rose Odor Exposure on Ictal Apnea (NCT07116421) | Clinical Trial Compass
RecruitingEarly Phase 1
Effect of Rose Odor Exposure on Ictal Apnea
United States40 participantsStarted 2025-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Early Phase 1, which means it's at a very early stage — what is currently known about the safety of exposing someone to rose odor during a seizure, and are there any risks I should be aware of before considering this?
2The trial is looking at whether rose odor exposure can reduce the number of seizures and apnea episodes — can you help me understand what ictal apnea is, and why reducing it might matter for my specific situation or risk of sudden unexpected death in epilepsy (SUDEP)?
3Since this study is measuring apnea episodes during seizures, does my seizure type or history even involve breathing problems, and would that affect whether this trial might be worth discussing for me?
4Given that this is an early-phase trial where the main goal is likely to establish feasibility and safety rather than prove the treatment works, should I consider optimizing my current anti-seizure medications first before thinking about an experimental approach like this?
5What would participation actually look like day-to-day — would I need to be monitored in a clinical setting during seizures, and how might that fit with my work, family, or caregiving responsibilities?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.