Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Dr
30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, from cognitive dysfunctions to premature mortality. Both seizures and their complications are modulated by patients' vigilance states, with a tight and bi-directional interplay between sleep and epilepsy
| Condition(s) | Epilepsy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, from cognitive dysfunctions to premature mortality. Both seizures and their complications are modulated by patients' vigilance states, with a tight and bi-directional interplay between sleep and epilepsy. Several epilepsy complications are associated with sleep, such as sleep-disordered breathing or Sudden and Unexpected Death in Epilepsy (SUDEP). SUDEP is a non-traumatic death, unrelated to a documented status epilepticus, which accounts for up 50% of premature deaths in epilepsy, with a cumulative risk of ≈ 10% at 40 years in patients with childhood-onset epilepsy. SUDEP typically occurs during sleep, after a nocturnal seizure, and primarily results from a postictal centra |
| Who can participate | 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 o |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Hospices Civils de Lyon |
| Locations | Bron, Rhone, France |
| Start date | 2024-11-04 |
| NCT ID | NCT06545214 |
| Official listing | https://clinicaltrials.gov/study/NCT06545214 |