Epilepsy
Conditions
Interventions
After a baseline period of three months, participants will start wearing a
seizure detection device with medical CE (either NightWatch or Epi-Care Free)
during the night.
Sponsors
Kempenhaeghe
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: At least 18 years old Living in a Dutch long-term care facility At least 1 suspected major, night-time epileptic seizure that requires medical assistance per month (this includes tonic-clonic seizures, tonic seizures longer than 30 seconds and/or hypermotor seizures) Willing to wear a seizure detection device No objection to video monitoring during the study Sufficient proficiency in the Dutch language to fill out the required questionnaires (with assistance if needed)
Exclusion criteria
Exclusion criteria: Already has adequate seizure detection available Will start using a seizure detection device within 3 months or less Has a movement disorder that manifests during the night
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this research is to investigate the effect of seizure detection devices on the number of valid and missed visits by caregivers to clients following an alarm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary parameters are the effect of seizure detection devices on quality of life (both general and disease specific), number of complications after 12 months and user experience of both healthcare workers and patients. Furthermore, specifically designed cost questionnaires will be designed based on the latest HTA-insights, in order to perform a cost-utility and cost-effectiveness analysis of the intervention. Due to randomized allocation of the two seizure detection devices, there will be data available regarding possible differences between these two devices. Even though this is not a part of the primary goal of this study, these data will be analyzed in order to determine whether there are differences between the two devices. | — |
Countries
Netherlands
Contacts
Public ContactJ.P. Dijk
Kempenhaeghe
Outcome results
None listed