Electroclinical Features of Sudden Unexpected Death in Ep... | NCT05423990

Studies
Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study

NCT05423990

Sponsor

Liu Yonghong

Status

Unknown status

Last Update Posted

Jan 18, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Sudden Unexpected Death in Epilepsy
Near-Sudden Unexpected Death in Epilepsy

Interventions

Video-Electroencephalography

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2022Actual

Primary Completion Date

Apr 1, 2024Estimated

Completion Date

Apr 1, 2024Estimated

First Submitted Date

Jun 14, 2022

First Submission Date that Met QC Criteria

Jun 14, 2022

First Posted Date

Jun 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2024

Last Update Posted Date

Jan 18, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video-Electroencephalography	Diagnostic Test	Three types of video EEG monitoring equipment produced by Nicolet, Bio-logic and Nihon Kohden were used to collect data in the multi-center. The 19-lead recording electrode was placed according to the international 10-20 system, and the average lead was used. The recording time was 24h. All patients underwent eyes open and closed test, intermittent photic stimulation and hyperventilation induction test.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The occurrence of SUDEP or near-SUDEP	Baseline, clinical characteristics and EEG markers of SUDEP patients were collected.	2022.04.01-2024.04.01

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with epilepsy who experience SUDEP or near-SUDEP identified in a multicenter study between April 2022 and April 2024.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Liu Yonghong		Xi'an	Shaanxi	710000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000080485	Sudden Unexpected Death in Epilepsy

Ancestor Terms

ID	Term
D004827	Epilepsy
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided