40 Participants Needed

Rose Odor for Epilepsy

WP
BJ
Overseen ByBrigitte Jia, BA
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the scent of roses (2-phenylethanol rose scent) can help reduce the risk of Sudden Unexpected Death in Epilepsy (SUDEP) for people with epilepsy. Participants will stay in the hospital, where researchers will monitor their brain and breathing activities while exposing them to a rose scent for 24 hours. The trial seeks adults with epilepsy who are already scheduled for a routine 48-hour EEG monitoring session at Vanderbilt University Medical Center. As an Early Phase 1 trial, this research focuses on understanding how the rose scent works in people, offering participants a unique opportunity to contribute to groundbreaking research.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that there should be no changes in seizure medications during the 48-hour monitoring period.

What prior data suggests that this method is safe for epilepsy patients?

Research has shown that 2-phenylethanol, a main component of rose scent, is generally safe. Studies have found that smelling rose scent might help individuals feel calm. Some possible risks include discomfort or a reaction to the scent, but these are usually minor. Participants might also experience discomfort from wearing a breathing belt, which is common when using such devices. Overall, existing evidence suggests that the treatment is well-tolerated.12345

Why do researchers think this study treatment might be promising?

Most treatments for epilepsy, like anti-seizure medications, work by stabilizing electrical activity in the brain. However, the rose scent treatment is unique because it uses 2-phenylethanol, a compound from rose oil, delivered through aromatherapy. This method introduces a non-invasive, potentially calming alternative that targets the brain through olfactory pathways. Researchers are excited about this because it could offer a new way to manage seizures without the side effects commonly associated with traditional medications.

What evidence suggests that rose scent might be an effective treatment for epilepsy?

Research has shown that the smell of roses, particularly 2-phenylethanol, might help calm people and reduce stress and depression. Early studies with mice suggested that this scent could lower the chance of death. This trial will compare two conditions: one group will be exposed to ambient rose scent via an aromatherapy diffuser, while another group will experience scentless room air. This offers hope for people with epilepsy, as it might reduce the risk of Sudden Unexpected Death in Epilepsy (SUDEP). The rose scent is generally safe, with few risks reported. While more research is needed, these early findings offer hope for its potential benefits in epilepsy care.12467

Are You a Good Fit for This Trial?

This trial is for epilepsy patients at risk of SUDEP who are undergoing routine inpatient EEG monitoring. Participants will be exposed to rose scent during additional EEG monitoring to study its effects on seizure-related apnea.

Inclusion Criteria

I am an adult over 18 with epilepsy.
Admission to the inpatient epilepsy monitoring unit (EMU) at Vanderbilt University Medical Center (VUMC)
I am having an EEG without any changes to my seizure medications for 48 hours.

Exclusion Criteria

I have had EEG monitoring for less than 48 hours without any interventions.
I am younger than 18 years old.
Patients who are not receiving EEG monitoring as a part of their inpatient admission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Control Arm

Participants undergo routine inpatient observational EEG monitoring for 24 hours on room air, wearing a respiratory belt.

24 hours
Inpatient stay

Exposure Arm

Participants undergo 24 hours of routine inpatient EEG monitoring with rose scent diffused in their room, wearing a respiratory belt.

24 hours
Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

Indefinite archival of information

What Are the Treatments Tested in This Trial?

Interventions

  • 2-phenylethanol rose scent
Trial Overview The intervention being tested is the exposure to 2-phenylethanol rose scent, using an essential oil diffuser, while participants undergo a standard observational EEG. The aim is to see if this can reduce the occurrence of ictal apnea associated with seizures.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Rose scent exposureExperimental Treatment1 Intervention
Group II: Room airActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

Citations

2-phenylethanol Odor Exposure for Epilepsy Apnea ...The study carries minimal risks, with rose scent exposure being generally safe and potentially having calming effects.
Rose Odor for Epilepsy · Recruiting Participants for Phase ...This study will investigate the potential benefits of rose scent in reducing the risk of Sudden Unexpected Death in Epilepsy (SUDEP) in patients with ...
5 Research Projects Win Funding ...The team aims to better explore the effects of 2-phenylethanol exposure on mortality, seizure frequency, and neuropsychiatric conditions in this ...
DSF Announces 2022 Grant AwardeesExciting preliminary data using a mouse model of DS suggests that mortality is significantly reduced by chronic exposure to this odor, our goal ...
Smell and Stress Response in the Brain - PubMed Central - NIHThus, the inhalation of rose oil containing 2-phenylethanol may be effective against depression and stress-related diseases. It was also ...
Safety Assessment of Rosa damascena-derived ...3 Although citronellol, geraniol, and nerol contents are relatively lower, the 2-phenylethanol content is higher in a Rosa damascena flower wax ...
Safety of active substances derived from Rosa damascena ...The data suggest that rose oil increases skin permeability while preserving barrier function ( Schmitt et al. 2010 ). Conclusion. The present ...
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