Sleep breathing study seeks clues to prevent sudden death in epilepsy
NCT ID NCT06545214
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hôpital Pierre Wertheimer
RECRUITINGBron, Rhone, 69500, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can lavender and lullabies help kids with epilepsy sleep better?
- Reading the Brain's signals to predict who benefits from deep brain stimulation
- Can a Comfort-Focused education program improve life with epilepsy?
- Can video games rewire young brains after injury?
- High-Fat Diet's effect on epilepsy: scientists track brain signals
- Epilepsy drug candidate put to the test in healthy volunteers