Epilepsy/Seizure
Conditions
Interventions
80 epileptic patients will be monitored with video-electroencephalogram and a wristband with accelerometer and sensors of vital signs (temperature, electrodermal activity, and heart rate), during thei
Device
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: The criteria of inclusion are age between 12 and 65 years old, diagnosis of epilepsy suspected or confirmed, and absence of skin lesions on wrist.
Exclusion criteria
Exclusion criteria: The criteria of exclusion are individual hospitalized at the video-EEG monitoring unit for less than 48 hours, individual displaying disconfort with the use of the wristband or with skin reaction potencially attributed to the use of the wristband, time of good quality monitoring of vital signs less than 10 hours across a sleep or wake period, individual whose diagnosis of epilepsy has not been confirmed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expected primary endpoint is the occurrence of clinical-electrographic seizure up to 24 hours after temperature monitoring across a complete sleep-wake cycle using a wristband with sensors have showed a ratio between the mean temperature during sleep over the mean temperature during the preceding wake period less than 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess if there is correlation between the time of occurrence of clinical-electrographic seizure and the mean temperature ratio between sleep and wake periods measured by Empatica E4 during the day preceding the seizure;Assess if there is correlation between the occurrence of clinical-electrographic seizure up to 24 hours following monitoring by Dixtal 2022 monitor or thermography camera and the ratio between the mean values of temperature during the sleep and the preceding wake period;Assess the time of occurrence of clinical-electrographic seizure during the monitoring by Dixtal 2022 monitor or thermography camera in function of the ratio between the mean temperature during the sleep and the preceding wake period;Correlate the occurrence of clinical-electrographic seizure up to 24h following the monitoring with the Empatica E4 wristband with sensors with the ratio of the mean electrodermal activity between sleep and wake and of the heart rate variability between sleep and wake;Assess the time of occurrence of clinical-electrographic seizure following the monitoring with the Empatica E4 wristband with sensors and the values of the ratio between the mean electrodermal activity during sleep and wake and the ratio between the heart rate variability during sleep and wake | — |
Countries
Brazil
Contacts
Public ContactAdriano Nogueira
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed