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New study aims to predict sudden death in severe epilepsy

NCT ID NCT05472389

Knowledge-focused Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how repeated seizures affect breathing and heart function in people with Dravet syndrome, a severe form of epilepsy. Researchers will monitor 92 children and adults for 24-48 hours using video, brain wave, heart, and breathing recordings. The goal is to find clues that could help prevent sudden unexpected death in epilepsy (SUDEP).

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could identify early warning signs for sudden unexpected death in epilepsy (SUDEP), paving the way for future preventive treatments.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient care, and results might not apply to all epilepsy types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

92 people

The number who actually took part.

Started

Oct 2022

Expected to finish

Sep 2035

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Children (\> 2 years and \< 18 years) and adult patients (\< 60 years) with established diagnosis of Dravet Syndrome * Adults protected by a guardianship or curatorship * Diagnosis of Dravet syndrome will be confirmed by PI of each study center based on medical history, type of seizures, EEG data and results of genetic testing * No restriction related to the seizure frequency * Patient (or patient's parents or legal representative) who gave its written informed consent to participate to the study * At least one of the parents and/or legal representative understanding and speaking national language * Written consent form signed by both parents * Absence of known current pregnancy and breastfeeding * Patient affiliated to its national health care system Exclusion Criteria: * Patients (children or adults) unable to tolerate at least 24 hours of video-EEG recordings (behavioural problems resulting in technical issues for appropriate EEG recordings) * Patients with congenital heart or lung disease * Patients with congenital abnormalities or diseases, other than the epilepsy, which could interfere with sleep * Subject in exclusion period of another study

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Conditions

The condition(s) this trial relates to.

Dravet syndrome Epilepsies, Myoclonic epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dravet syndrome Epilepsy

Contacts and locations

Locations

  • Department of Paediatrics and Paediatric Neurology, Antwerp University Hospital

    Edegem, 2650, Belgium

  • HFME Hospices Civils de Lyon

    Bron, Rhone, 69500, France

  • Hôpital Neurologique Pierre Wertheimer Hospices Civils de Lyon

    Bron, Rhone, 69500, France

  • Klinik und Poliklinik für Epileptologie, Universitätsklinikum

    Bonn, 53127, Germany

More trials for these conditions

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