Recruiting
Early Phase 1

Rose Scent

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07116421

Conditions

Epilepsy

Sudden Unexpected Death in Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

2-phenylethanol rose scent

Study Details

Brief 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.

Conditions

Epilepsy

Sudden Unexpected Death in Epilepsy

Study ID

NCT07116421

Start date

Jul 1, 2025

Status verified date

Jun, 2026

Completion date

May 8, 2027

Anticipated

Primary completion date

May 8, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Rose scent exposure

Ambient rose scent exposure via aromatherapy diffuser into patient room for 24 hours

no intervention: Room air

Scentless room air for 24 hours

Interventions

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.

Primary outcome measure

  • Number of ictal episodes [ Time Frame: 24 hours ]
  • Number of apneic episodes [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Brigitte Jia, BA

925-378-9234brigitte.jia@vanderbilt.edu

William P Nobis, MD, PhD

615-936-5776william.p.nobis@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Brigitte Jia, BA

925-378-9234brigitte.jia@vanderbilt.edu

Lilly He, BA

lilly.he@vanderbilt.edu

Principal Investigator:

William P Nobis, MD, PhD

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • SUDEP
  • Epilepsy
  • Sudden Unexpected Death in Epilepsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-06-11.