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Sleep breathing study seeks clues to prevent sudden death in epilepsy

NCT ID NCT06545214

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 breathing and waking up from sleep are linked in people with drug-resistant epilepsy. About 60 adults with epilepsy and healthy volunteers will have their breathing tested during deep sleep. The goal is to understand why some people with epilepsy are at risk for sudden unexpected death (SUDEP) and find ways to prevent it.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jan 2027

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Patients : 1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study 2. Aged 18 to 55 years old 3. Diagnosis of focal epilepsy 4. Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy 5. Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) during the past 18 months 6. Patients who had undergone long-term video-EEG (VEEG) monitoring for presurgical evaluation in the past ten years within the Department of Functional Neurology and Epileptology at Hospices Civils de Lyon, ensuring access to detailed information about: * occurrence of transient respiratory dysfunction during the focal seizures, transient hypoxemia during strictly focal seizures being observed in 40% of patients(39) and in 87% of patients with at least one FBTCS during the VEEG monitoring(46) * localization of the epileptogenic zone, the risk of peri-ictal respiratory dysfunction being greater in seizures of temporal lobe origin than in extra-temporal seizures, even after FBTCS Healthy subjects 1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study 2. Aged 18 to 55 years old Exclusion Criteria: Patients 1. Ongoing or chronic respiratory and/or cardiac insufficiency 2. Obstructive sleep-apnea syndrome 3. Ongoing treatment with selective serotonin reuptake inhibitor 4. Patient treated with vagal nerve stimulation 5. Pregnant women or breastfeeding women, based on declarations at V0 6. Persons receiving psychiatric care 7. Persons deprived of their liberty by a judicial or administrative decision 8. Adults subject to a legal protection measure (guardianship, curatorship) 9. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme 10. Positive urine pregnancy test at V1, if applicable Healthy subjects 1. History of epilepsy 2. Ongoing or chronic respiratory and/or cardiac insufficiency 3. Obstructive sleep-apnea syndrome 4. Pregnant women, women in labor or breastfeeding women, based on declarations at V0 5. Persons receiving psychiatric care 6. Persons deprived of their liberty by a judicial or administrative decision 7. Adults subject to a legal protection measure (guardianship, curatorship) 8. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme 9. Positive urine pregnancy test at V1, if applicable

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Conditions

The condition(s) this trial relates to.

epilepsy Sudden Unexpected Death in Epilepsy

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpital Pierre Wertheimer

    RECRUITING

    Bron, Rhone, 69500, France

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