Understanding breathing and arousal changes in patients with drug-resistant epilepsy
Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy
This study looks at how breathing problems and sleep changes affect adults with drug-resistant epilepsy to better understand their risk of sudden death related to seizures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron, Rhone) |
| Trial ID | NCT06545214 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between respiratory dysfunction and arousal states in patients suffering from drug-resistant epilepsy. It focuses on patients aged 18 to 55 who have experienced multiple focal to bilateral tonic-clonic seizures. The methodology includes video-EEG monitoring, respiratory monitoring, and polysomnography, along with hypercapnic challenges to assess respiratory responses during wakefulness and sleep. The goal is to better understand the interplay between seizures, sleep, and respiratory function, particularly in relation to the risk of Sudden Unexpected Death in Epilepsy (SUDEP).
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with focal epilepsy that is resistant to treatment and who have experienced multiple focal to bilateral tonic-clonic seizures.
Not a fit: Patients with epilepsy that is well-controlled by medication or those outside the age range of 18 to 55 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of seizure-related complications, potentially reducing the risk of SUDEP.
How similar studies have performed: While the specific approach of this study may be novel, there is existing literature indicating a connection between respiratory dysfunction and epilepsy complications, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron, Rhone
- Hôpital Pierre Wertheimer — Bron, Rhone, France (Recruiting)
Study contacts
- Study coordinator: Sylvain Pr Rheims
- Email: sylvain.rheims@chu-lyon.fr
- Phone: 0472357106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.