Risk Factors for Sudden Unexplained Death in Epilepsy (NCT01662453) | Clinical Trial Compass
RecruitingNot Applicable
Risk Factors for Sudden Unexplained Death in Epilepsy
United States800 participantsStarted 2011-06
Plain-language summary
The main purpose of this study is to develop a North American registry for SUDEP cases; requesting family members of epilepsy patients who died suddenly of unclear causes (SUDEP) to contact the study team. The family members who decide to participate in the study will be asked to complete a brief telephone interview about their loved one's epilepsy and seizure history and the circumstances of his or her death. If the death has occurred within the past 24 hours, and the family is willing to consider donating tissue to the study, the subject will be transferred to the Autism Tissue Program, and the remainder of the phone interview will be conducted at a later time.
In addition to the phone interview, the family will be asked to provide access to the deceased's medical records. Any costs involved in obtaining medical records will be covered by the study, and all medical information will remain completely confidential.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Sudep Group Subjects diagnosed with epilepsy whose cause of death was sudden and unexplained, and whose families are willing to participate, will be included in the study.
Control Group For the control group, we will include any patient diagnosed with epilepsy currently in the care of the NYU Comprehensive Epilepsy Center, willing and able to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically focused on SUDEP — sudden unexplained death in epilepsy — how does my particular type of epilepsy or seizure pattern affect my personal risk, and is that something this trial might help clarify for me?
2This trial is listed as actively recruiting and seems to be observational, tracking incidence and risk factors rather than testing a new treatment — does that mean participating would involve monitoring and data collection rather than any change to my current medication or care plan?
3Given that the study is measuring risk factors for SUDEP, would joining this research help my care team identify anything specific about my situation that could lead to changes in how we manage my epilepsy to reduce that risk?
4Are there alternative steps my doctor would recommend right now — like adjusting my seizure medications, using a seizure detection device, or changing sleep safety practices — while we consider whether participating in this observational study makes sense for me?
5Since this trial is Phase NA, meaning it's not testing a new drug or intervention, what would my ongoing commitment look like in terms of visits, data sharing, or follow-up, and how might that fit with my current treatment schedule?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.