Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
ID07116421

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

Led by Vanderbilt University Medical Center · Updated on 2025-08-11

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether exposure to rose scent can reduce the risk of sudden unexpected death in epilepsy (SUDEP) by studying adult patients with epilepsy undergoing inpatient monitoring. The study focuses on understanding how rose scent exposure affects seizure-related breathing difficulties, using electroencephalography (EEG) and respiratory monitoring. This early-phase trial aims to uncover potential new ways to help patients with epilepsy by exploring the link between smell and seizure activity. Participants will first undergo 24 hours of routine EEG monitoring without rose scent exposure while wearing a respiratory belt to measure breathing. Then, for another 24 hours, they will continue EEG and respiratory monitoring while a diffuser releases rose essential oil scent into their hospital room. The rose scent is given as three drops diffused continuously over 24 hours. Mood assessments and a smell identification test are also done during the study period. During the 48-hour study, participants will be monitored closely with EEG and a respiratory belt to record seizure and breathing events. They will complete mood surveys before and after rose scent exposure and take a smell recognition test at the start. The study measures the number of seizure episodes and breathing pauses during both 24-hour periods. Participants are free to engage in normal activities during their hospital stay, with the main requirement being to wear the respiratory belt most of the time.

CONDITIONS

Brief Title

Effect of Rose Odor Exposure on Ictal Apnea

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Monitoring

Duration - 24 hours

Participants undergo routine inpatient observational EEG monitoring on room air while wearing a respiratory belt to measure respiratory function.

Continuous monitoring over 24 hours

Rose Scent Exposure Treatment

Duration - 24 hours

Participants continue routine inpatient EEG monitoring while exposed to rose scent via an essential oil diffuser in their room and wearing a respiratory belt for respiratory monitoring.

Continuous monitoring over 24 hours

Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

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Research Team

B

Brigitte Jia, BA

W

William P Nobis, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Sensory stimulation reduces seizure severity but not afterdischarge duration of partial seizures kindled in the hippocampus at threshold intensities.

Pamela A Valentine, Sonja L Fremit, G Campbell Teskey

https://pubmed.ncbi.nlm.nih.gov/16039062