Effect of Rose Odor Exposure on Ictal Apnea

NCT07116421 | Recruiting Early Phase 1

• 1 other identifier: 241251
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

SUDEP; Epilepsy; Sudden Unexpected Death in Epilepsy

Outcome Measures

Primary Outcomes (2)

• Number of ictal episodes

  Number of ictal episodes measured via EEG

  24 hours

• Number of apneic episodes

  Number of brief cessations in breathing captured via respiratory belt

  24 hours

Study Arms (2)

Rose scent exposure

EXPERIMENTAL

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

Drug: 2-phenylethanol rose scent

Room air

NO INTERVENTION

Scentless room air for 24 hours

Interventions

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.

Also known as: Rose aromatherapy, Rose smell, Rose oil, Rose diffusor scent

Rose scent exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Related Publications (10)

• Yilmaz Y, Turk BG, Ser MH, Sut NY, Sahin S, Yildiz EP, Bektas G, Teber ST, Tekeli H, Ozkara C. Seizure treatment with olfactory training: a preliminary trial. Neurol Sci. 2022 Dec;43(12):6901-6907. doi: 10.1007/s10072-022-06376-2. Epub 2022 Sep 6.

  PMID: 36066675 BACKGROUND

• Valentine PA, Fremit SL, Teskey GC. Sensory stimulation reduces seizure severity but not afterdischarge duration of partial seizures kindled in the hippocampus at threshold intensities. Neurosci Lett. 2005 Nov 4;388(1):33-8. doi: 10.1016/j.neulet.2005.06.028.

  PMID: 16039062 BACKGROUND

• Rhone AE, Kovach CK, Harmata GI, Sullivan AW, Tranel D, Ciliberto MA, Howard MA, Richerson GB, Steinschneider M, Wemmie JA, Dlouhy BJ. A human amygdala site that inhibits respiration and elicits apnea in pediatric epilepsy. JCI Insight. 2020 Mar 26;5(6):e134852. doi: 10.1172/jci.insight.134852.

  PMID: 32163374 BACKGROUND

• O'Neal TB, Shrestha S, Singh H, Osagie I, Ben-Okafor K, Cornett EM, Kaye AD. Sudden Unexpected Death in Epilepsy. Neurol Int. 2022 Jul 18;14(3):600-613. doi: 10.3390/neurolint14030048.

  PMID: 35893283 BACKGROUND

• Nobis W, Huffman R, Mitchell A, Hannalla M. 512 Odorant exposure decreases mortality in a Dravet Syndrome mouse model. J Clin Transl Sci. 2023;7(Suppl 1):145. Published 2023 Apr 24. doi:10.1017/cts.2023.511

  BACKGROUND

• Nobis WP, Gonzalez Otarula KA, Templer JW, Gerard EE, VanHaerents S, Lane G, Zhou G, Rosenow JM, Zelano C, Schuele S. The effect of seizure spread to the amygdala on respiration and onset of ictal central apnea. J Neurosurg. 2019 Apr 5;132(5):1313-1323. doi: 10.3171/2019.1.JNS183157. Print 2020 May 1.

  PMID: 30952127 BACKGROUND

• Nguyen MQ, Ryba NJ. A smell that causes seizure. PLoS One. 2012;7(7):e41899. doi: 10.1371/journal.pone.0041899. Epub 2012 Jul 27.

  PMID: 22848650 BACKGROUND

• Motoki A, Akamatsu N, Fumuro T, Miyoshi A, Tanaka H, Hagiwara K, Ohara S, Kamada T, Shigeto H, Murai H. Characteristics of olfactory dysfunction in patients with temporal lobe epilepsy. Epilepsy Behav. 2021 Dec;125:108402. doi: 10.1016/j.yebeh.2021.108402. Epub 2021 Nov 12.

  PMID: 34775249 BACKGROUND

• Lunardi MS, Lin K, Mameniskiene R, Beniczky S, Bogacz A, Braga P, Guaranha MSB, Yacubian EMT, Samaitiene R, Baykan B, Hummel T, Wolf P. Olfactory stimulation induces delayed responses in epilepsy. Epilepsy Behav. 2016 Aug;61:90-96. doi: 10.1016/j.yebeh.2016.05.022. Epub 2016 Jun 23.

  PMID: 27344500 BACKGROUND

• Li Z, Chen L, Xu C, Chen Z, Wang Y. Non-invasive sensory neuromodulation in epilepsy: Updates and future perspectives. Neurobiol Dis. 2023 Apr;179:106049. doi: 10.1016/j.nbd.2023.106049. Epub 2023 Feb 20.

  PMID: 36813206 BACKGROUND

Related Links

• Rose Scent
• Aroma Ace Diffuser
• UPSIT Smell Test

MeSH Terms

Conditions

Epilepsy; Sudden Unexpected Death in Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brigitte Jia, BA

CONTACT

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

William P Nobis, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 11, 2025
• Study Start: July 1, 2025
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal, to achieve aims in approved proposal.

Locations

US (1)