Effect of Rose Odor Exposure on Ictal Apnea

ConditionsEpilepsy Sudden Unexpected Death in Epilepsy

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

2-phenylethanol rose scent
Drug
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Rose scent exposureExperimental treatment 1 intervention

Group B: Room airNo intervention 0 interventions

Trial outcomes

Primary outcomes

Number of ictal episodes

Number of ictal episodes measured via EEG

Time frame

24 hours

Number of apneic episodes

Number of brief cessations in breathing captured via respiratory belt

Time frame

24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

Source ClinicalTrials.gov

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