The primary objective of this trial are to assess the clinical usefulness (in terms of sensitivity and positive predictive value of 1. Combined heart rate and movement detection2. And the added value of video and audio detection in a population of…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The combined analysis of heart rate and accelerometry, the added value of
video/audio analysis and the technical performance are primary endpoints.
Secondary outcome
Secondary end points are the performances of heart rate, accelerometry, video
and audio alone, comparison with the Emfit bed sensor, quality of life,
optimalisation of care and levels of trust of caregivers in system performance.
Background summary
Seizure detection is important in the care of epilepsy patients with a mental
impairment and children with severe epilepsy for the following reasons
- these patients often do not report seizures by themselves
- current alarm systems based on audio severely underreport seizures
- seizures in these often refractory patients may require acute intervention,
medication in case of seizure clusters, may lead to status epilepticus and
cardiopulmonary instability, a risk for SUDEP (sudden unexplained death in
epilepsy).
- seizures can result in other complications (falls, headache, *hang-over*
fatigue, inability to work) that can be prevented by early detection.
- accurate knowledge of seizure frequency is necessary to adjust anti-epileptic
drugs
- seizure detection may enhance the feeling of safety of caregivers and parents
and improve their sleep and quality of life.
Although increasingly reliable bed-sensors become available there is still a
need for further improvement of seizure detection devices.
We developed a seizure detection device for home monitoring of these seizures
during the night. This is a multimodal device which automatically analyses
heart rate, accelerometry, video and audio signals.
Study objective
The primary objective of this trial are to assess the clinical usefulness (in
terms of sensitivity and positive predictive value of
1. Combined heart rate and movement detection
2. And the added value of video and audio detection in a population of adult
patients with mental impairment and children from 2 -18 years of age with
severe refractory epilepsy
And the feasibility and technical performance of the sensor system
This will be done in and intention-to-diagnose set-up that includes the risk of
technical failure
Secondary objectives of this trial are quality of life and trust of caregivers
(value sensitive design list). The performances of the individual modalities
(heart rate, accelerometry, video audio), comparison with the Emfit bed sensor.
Study design
This is a non-randomized observational clinical trial in 30 children of 2-18
years of age and mentally impaired subjects with medically intractable
epilepsy. Each subject will undergo all-night monitoring during 3 months in
which the multimodal seizure detection system will be applied in the home
situation of the patient. Expert review of the nocturnal video recordings will
serve as a gold standard. Seizures will be stratified according to type and
severity.
Study burden and risks
There are no risks and there is no burden associated with participation in the
study.
Sterkselseweg 65
Heeze 5591 VE
NL
Sterkselseweg 65
Heeze 5591 VE
NL
Listed location countries
Age
Inclusion criteria
Subjects who meet all of the following criteria are eligible for this trial:
1. Between 2 and 18 years of age with or without mental impairment, or between 18 - 65 years with a mental impairment.
2. Major motor seizures defined as tonic-clonic, generalized tonic, hypermotor or series of myoclonic seizures.
3. Minimal nocturnal seizure frequency: 1/month.
4. The mentally impaired patients all live in the long-term facilities at Kempenhaeghe or SEIN. Children may live in their family home.
5. Informed consent form signed by legal representatives.
Exclusion criteria
Subjects meeting one or more of the following criteria cannot be selected:
1. Intensive non-epileptic movement patterns such as severe choreatiform movements due to birth defects, intensive sleep walking, frequent night terrors (> 1/night)
2. Only minor motor seizures: non-generalised or short (< 10 sec.) tonic seizures or isolated myoclonias.
3. Pacemaker
4. Inability to comply to the trial procedure
5 Dark colored skin.
Design
Recruitment
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 | NL47654.041.14 |