NCT06006442

Brief Summary

This case-crossover study evaluates the association between vaping and seizures in patients of a large academic medical center who admits to vaping and hav a planned ambulatory EEG ordered.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

August 17, 2023

Last Update Submit

October 7, 2023

Conditions

Evaluate the Association of Vaping With Seizures

Outcome Measures

Primary Outcomes (1)

  • Odds of Vaping Related Seizure

    Odds ratio of vaping during periods of seizures versus periods of seizure freedom.

    The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping

Secondary Outcomes (1)

  • Odds of Increased Interictal Discharges After Vaping

    The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping

Study Arms (1)

DHMC Ambulatory EEG Patients

Dartmouth Hitchcock Medical Center (DHMC) patients aged 21 years or older who already have planned ambulatory EEG study ordered and admit to vaping.

Behavioral: Vaping

Interventions

VapingBEHAVIORAL

Subjects will be smoking the vapnig products that they admitted to using at baseline in the personal life prior to this study

DHMC Ambulatory EEG Patients

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any DHMC patient aged 21 years or above with a planned ambulatory electroencephalogram (EEG) of any duration, regardless of diagnosis or reason for study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Peter S Tatum, DO

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epilepsy Fellow

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 31, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10

Locations

US(1)