Sudden Unexpected Death in EpilepsyNCT05423990
Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study
An observational study of Sudden Unexpected Death in Epilepsy and Near-Sudden Unexpected Death in Epilepsy, run by Liu Yonghong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sudden Unexpected Death in Epilepsy, Near-Sudden Unexpected Death in Epilepsy
- What is being tested?
- Video-Electroencephalography
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with epilepsy who experience SUDEP or near-SUDEP identified in a multicenter study between April 2022 and April 2024.
Who may be able to join
- Patients with epilepsy who meet SUDEP or near-SUDEP diagnosis,
- Giving written informed consent to participate in the study from relatives or caregivers.
Who cannot join
- Refusing to recruitment from relatives or caregivers.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Video-Electroencephalography
- Medical subject headings
- Sudden Unexpected Death in Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-ElectroencephalographyDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of SUDEP or near-SUDEP
Baseline, clinical characteristics and EEG markers of SUDEP patients were collected.
Measured: 2022.04.01-2024.04.01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Unexpected Death in EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Yonghong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Yonghong, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423990
- Sponsor's protocol ID
- KY20222037-C-1
- Status last verified
- Jan 2024
- First submitted
- 14 Jun 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroclinical Features of Sudden Unexpected Death in Epilepsy (SUDEP) : a Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT05423990
- Acronym / sponsor ID
- KY20222037-C-1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liu YonghongUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with epilepsy who experience SUDEP or near-SUDEP identified in a multicenter study between April 2022 and April 2024.
Key inclusion criteria (2 listed)
- Patients with epilepsy who meet SUDEP or near-SUDEP diagnosis,
- Giving written informed consent to participate in the study from relatives or caregivers.
Key exclusion criteria (1 listed)
- Refusing to recruitment from relatives or caregivers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-ElectroencephalographyThree 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. | Diagnostic test | – |
Primary outcome
The occurrence of SUDEP or near-SUDEP
Time frame: 2022.04.01-2024.04.01
Baseline, clinical characteristics and EEG markers of SUDEP patients were collected.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Unexpected Death in Epilepsy and Near-Sudden Unexpected Death in Epilepsy, run by Liu Yonghong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of SUDEP or near-SUDEP (time frame: 2022.04.01-2024.04.01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.