Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545214
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARROUSEL
Brief 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 central respiratory dysfunction in patients with generalized convulsive seizure GCS suggesting that interaction between respiratory dysfunction and sleep state may play a role in its pathophysiology
Most of patients with drug-resistant seizures demonstrate transient peri-ictal apnea and hypoxemia especially in the aftermath of a GCS Experimental and clinical data suggest that most SUDEP primarily result from a fatal seizure-related respiratory arrest In patients whose SUDEP had occurred during long-term video-EEG monitoring we observed fatal postictal central apnea after a nocturnal GCS in all SUDEP Accordingly it is currently hypothesized that in a subgroup of patients repetition of seizures may contribute to chronic alteration of respiratory regulation which may increase the risk of fatal postictal central respiratory arrest Finally post-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla
The complex network that regulates arousal and sleep and the respiratory network are strongly interconnected Impairment of the interaction between central respiratory control and arousal systems has been reported in several clinical situations including sleep apnea syndrome sudden infant death syndrome or Prader-Willi Syndrome In epilepsy preclinical data in rodents indirectly support a role for 5HT in the impairment of the interactions between the arousal and respiratory systems in the cascade of events leading to SUDEP However no direct evidence is available and the link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet
Most of patients with drug-resistant seizures demonstrate transient peri-ictal apnea and hypoxemia especially in the aftermath of a GCS Experimental and clinical data suggest that most SUDEP primarily result from a fatal seizure-related respiratory arrest In patients whose SUDEP had occurred during long-term video-EEG monitoring we observed fatal postictal central apnea after a nocturnal GCS in all SUDEP Accordingly it is currently hypothesized that in a subgroup of patients repetition of seizures may contribute to chronic alteration of respiratory regulation which may increase the risk of fatal postictal central respiratory arrest Finally post-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla
The complex network that regulates arousal and sleep and the respiratory network are strongly interconnected Impairment of the interaction between central respiratory control and arousal systems has been reported in several clinical situations including sleep apnea syndrome sudden infant death syndrome or Prader-Willi Syndrome In epilepsy preclinical data in rodents indirectly support a role for 5HT in the impairment of the interactions between the arousal and respiratory systems in the cascade of events leading to SUDEP However no direct evidence is available and the link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None