Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study
Sponsor
Liu Yonghong (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05423990
Collaborator
(none)
30
1
24
1.2
Study Details
Study Description
Brief Summary
Sudden unexpected death in epilepsy (SUDEP) is regarded as a leading cause of premature death in epilepsy patients. We aim to capture the whole process of SUDEP and near-SUDEP occurrence in patients with epilepsy, and expolre video-electroencephalograph (V-EEG) changes and marker. A Chinese multicenter study was carried out to determine electroencephalo-graph marker related to SUDEP to provide a scientific basis for the prevention of SUDEP in patients with epilepsy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study
Actual Study Start Date
:
Apr 1, 2022
Anticipated Primary Completion Date
:
Apr 1, 2024
Anticipated Study Completion Date
:
Apr 1, 2024
Outcome Measures
Primary Outcome Measures
- The occurrence of SUDEP or near-SUDEP [2022.04.01-2024.04.01]
Baseline, clinical characteristics and EEG markers of SUDEP patients were collected.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with epilepsy who meet SUDEP or near-SUDEP diagnosis,
-
Giving written informed consent to participate in the study from relatives or caregivers.
Exclusion Criteria:
- Refusing to recruitment from relatives or caregivers.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Liu Yonghong | Xi'an | Shaanxi | China | 710000 |
Sponsors and Collaborators
- Liu Yonghong
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Liu Yonghong,
professor,
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT05423990
Other Study ID Numbers:
- KY20222037-C-1
First Posted:
Jun 21, 2022
Last Update Posted:
Jun 21, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: