Effect of Rose Odor Exposure on Ictal Apnea

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07116421
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Epilepsy
  • Sudden Unexpected Death in Epilepsy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Jun 2026
Primary completion
May 8, 2027
Completion
May 8, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

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

Primary Outcome Measure

Number of ictal episodes [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Brigitte Jia, BA
[email protected]
925-378-9234
Lilly He, BA
[email protected]
William P Nobis, MD, PhD (PRINCIPAL_INVESTIGATOR)
Brigitte Jia, BA (SUB_INVESTIGATOR)
Lilly He, BA (SUB_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Vanderbilt University Medical Center· Nashville, TN

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