1. To test the performance of the wearable SDD (Nightwatch) prospectively and the remote SDDs (video and audio) retrospectively in a family home setting. 2. To explore the feasibility of the Nightwatch
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will measure the performance of the Nightwatch and the video & audio
algorithms through calculation of sensitivity, positive predictive value, false
alarm rate and % time with valid signal allowing proper detection.
Secondary outcome
We will evaluate feasibility of the Nightwatch through surveys on quality of
life, sleep, pearental strain, and medical consumption and costs questionnaires
and interviews with parent(s)/representative(s).
Background summary
Various remote and wearable sensor devices have been assessed for the
detection of potentially dangerous seizures, with limited impact on epilepsy
care so far. Our remote and wearable seizure detection devices (SDDs) have
demonstrated promising results with high sensitivity.
Study objective
1. To test the performance of the wearable SDD (Nightwatch) prospectively and
the remote SDDs (video and audio) retrospectively in a family home setting.
2. To explore the feasibility of the Nightwatch
Study design
A home-based prospective SDD study with prospective validation of our wearable
SDD.
Study burden and risks
Implementing SDDs is not considered to pose any substantial risk. Study
participation can be a burden for the family though, due to impact of the
devices on privacy and time spent on the questionnaires & interviews.
Participation does, however, also offer better insight for the parents in the
actual nocturnal seizure activity of their child, demonstrates the added value
of the Nightwatch and may help them to timely alert to major seizures.
Laan v. NOI 334
Den Haag 2593 CE
NL
Laan v. NOI 334
Den Haag 2593 CE
NL
Listed location countries
Age
Inclusion criteria
• Age 4-16 years
• Diagnosis of refractory epilepsy with >=1 major nocturnal seizure per week.
• Treated at one of the following epilepsy centers: SEIN, Kempenhaeghe or UMCU.
• Written informed consent by legal representatives (mostly parents) and also
by the subject when aged >=12 years and capable of signing informed consent.
Exclusion criteria
• Intensive non-epileptic movement patterns such as severe choreatiform
movements, intensive sleep walking, or frequent night terrors (> 1/week).
• Minor motor seizures only, i.e. non-generalized or short (< 10 sec.) tonic
seizures or isolated myoclonias that are self-limited and do not require
intervention.
• Presence of a pacemaker or cardiac arrhythmias that may generate false alarms
(e.g. supraventricular tachycardia).
• Inability to comply to the trial procedure.
• Skin characteristics (e.g. tattoo) that may affect photoplethysmography and
thereby influence performance of the Nightwatch .
• Dependence on another SDD (e.g. Emfit or saturation monitor). Simultaneous
use of a baby phone (or other types of microphones) is permitted.
• Subjects who are not sleeping alone in the bed (i.e. co-sleeping in the
parents*/guardians* bed influences the remote SDD). We do not allow subjects
and parents/guardians to change their sleeping habits for the duration of the
study only.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62995.041.17 |