Recruiting

2-phenylethanol Odor Exposure for Epilepsy Apnea Prevention

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What is being tested

2-phenylethanol rose scent

Drug
Who is being recruted

Sudden Unexpected Death in Epilepsy
+5

+ Brain Diseases
+ Central Nervous System Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Early Phase 1
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorVanderbilt University Medical Center
Study ContactBrigitte Jia, BAMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2025Actual date on which the first participant was enrolled.

This study explores the potential of using rose scent as a way to prevent sudden unexpected death in epilepsy (SUDEP), which affects about 1 in 1000 epilepsy patients each year. SUDEP often occurs due to breathing issues during seizures, but the exact cause is still unclear, making it hard to treat. By studying adult epilepsy patients in a hospital setting, researchers aim to see if exposure to the scent of roses can improve respiratory function during seizures, possibly reducing the risk of SUDEP. This study hopes to provide a better understanding of how scents might help manage epilepsy and save lives. Participants in the study will be adults admitted for epilepsy monitoring, where they will wear a non-invasive respiratory belt and undergo routine EEG monitoring. Initially, they will be tested for their ability to identify common scents and their mood will be assessed. Over the course of the study, participants will spend 24 hours in a room with no scent exposure and another 24 hours with rose scent diffused in the room. The researchers will evaluate changes in seizure activity and breathing patterns by comparing data from these two periods. The study carries minimal risks, with rose scent exposure being generally safe and potentially having calming effects.

Official TitleEffect of 2-phenylethanol Odor Exposure on Ictal Apneic Episode Occurrence Rate in Patients With Epilepsy 
NCT07116421
Principal SponsorVanderbilt University Medical Center
Study ContactBrigitte Jia, BAMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different treatments one after the other, switching from one to another during the study. This helps researchers understand how individuals respond to multiple treatments.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Sudden Unexpected Death in Epilepsy
Brain Diseases
Central Nervous System Diseases
Death
Death, Sudden
Epilepsy
Nervous System Diseases
Pathologic Processes
Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Ambient rose scent exposure via aromatherapy diffuser into patient room for 24 hours

Name: 2-phenylethanol (rose scent). Dose: 3 drops, diffused into room air over 24 hours. Frequency: Once over 24 hours. Route of administration: Essential oil diffuser. Manufactured by: The Essential Oil Company in Portland, OR. Manufacturing details: The rose scent is purified by hydrodistillation, shelf-stable, and in terms of verification of quality has been previously used in a peer-reviewed and IRB-approved study by Woo et al (2023) published in Frontiers in Neuroscience. Preparation: The Key Personnel listed in the study's IRB will prepare the rose essential oil scent by squeezing 3 drops of the product from the manufactured bottle into the essential oil compartment of the "Aroma Ace™ MINI Diffuser" essential oil diffuser, corresponding with both the rose essential oil and diffuser manufacturers' instructions for each product respectively.
Study Objectives
Primary Objectives

Number of ictal episodes measured via EEG

Number of brief cessations in breathing captured via respiratory belt

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Vanderbilt University Medical CenterNashville, United StatesSee the location
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One Study Center
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