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NCT07116421 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Rose Odor Exposure on Ictal Apnea
A Early Phase 1 study of Epilepsy and Sudden Unexpected Death in Epilepsy, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT07116421 is a Early Phase 1 study of Epilepsy and Sudden Unexpected Death in Epilepsy that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 40 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07116421, a Early Phase 1 study of Epilepsy and Sudden Unexpected Death in Epilepsy, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG 2-phenylethanol rose scent
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-07-01 |
| Est. Completion | 2026-05-08 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07116421
The ClinicalTrials.gov registry entry for NCT07116421 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (96% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 1 intervention - of which 2-phenylethanol rose scent is the first listed.
NCT07116421 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT07116421 about?
NCT07116421 is a clinical study titled "Effect of Rose Odor Exposure on Ictal Apnea". 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 observat...
What is the current status of trial NCT07116421?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2025-07-01. Estimated completion is 2026-05-08.
What conditions does trial NCT07116421 study?
This clinical trial studies the following conditions: Epilepsy, Sudden Unexpected Death in Epilepsy.
What interventions are being tested in trial NCT07116421?
The interventions under investigation include: 2-phenylethanol rose scent (DRUG).
Who is sponsoring clinical trial NCT07116421?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07116421 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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