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RECRUITING
NCT07116421
EARLY_PHASE1

Effect of Rose Odor Exposure on Ictal Apnea

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Official title: Effect of 2-phenylethanol Odor Exposure on Ictal Apneic Episode Occurrence Rate in Patients With Epilepsy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-01

Completion Date

2026-05-08

Last Updated

2025-08-11

Healthy Volunteers

No

Interventions

DRUG

2-phenylethanol rose scent

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.

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States