NCT07116421 Effect of Rose Odor Exposure on Ictal Apnea
| NCT ID | NCT07116421 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-05-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-07-01 with a primary completion date of 2026-05-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07116421 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07116421 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07116421 currently recruiting?
Yes, NCT07116421 is actively recruiting participants. Contact the research team at brigitte.jia@vanderbilt.edu for enrollment information.
Where is the NCT07116421 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07116421 clinical trial?
NCT07116421 is sponsored by Vanderbilt University Medical Center. The trial plans to enroll 40 participants.
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