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

NCT05423990 | Unknown

• 1 other identifier: KY20222037-C-1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The occurrence of SUDEP or near-SUDEP

  Baseline, clinical characteristics and EEG markers of SUDEP patients were collected.

  2022.04.01-2024.04.01

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with epilepsy who meet SUDEP or near-SUDEP diagnosis,
• Giving written informed consent to participate in the study from relatives or caregivers.

You may not qualify if:

• Refusing to recruitment from relatives or caregivers.

Sponsors & Collaborators

• Liu Yonghong: lead

Study Sites (1)

Liu Yonghong

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Conditions

Sudden Unexpected Death in Epilepsy

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

CN (1)