The purpose of this study is to determine whether a NightWatch worn on the leg detects the same seizures as a NightWatch worn on the arm. In addition, the signal quality of both devices will be examined.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
- Medical device
N.a.
Outcome measures
Primary outcome
<p>The primary outcome measure of this study is whether the NightWatch on the leg detects the same seizures as the NightWatch on the arm.</p>
Secondary outcome
<p>Secondary outcome measures are the quality of heart rate data, amount of time the device records being in “rest state,” and which algorithm has triggered alarm.</p>
Background summary
Having major, epileptic seizures during the night can pose great risks. Therefore, it is important to detect these seizures so that a caregiver can be alerted. NightWatch is a seizure detection device that has been extensively scientifically tested for detecting seizures on the arm. In some cases, however, there is a preference for wearing NightWatch on the leg. There is currently no scientific evidence for the effectiveness of NightWatch on the leg.
Study objective
The purpose of this study is to determine whether a NightWatch worn on the leg detects the same seizures as a NightWatch worn on the arm. In addition, the signal quality of both devices will be examined.
Study design
This study is designed as an intervention study in which participants will temporarily wear a second NightWatch around their leg.
Intervention
Participants will wear a second NightWatch worn around their leg for 4 weeks.
Study burden and risks
Participation in this study carries no specific risks, and the additional strain is minimal. Participants will wear an extra NightWatch around the leg for 4 weeks, but they are already used to sleeping with a NightWatch every night. In addition, participants are asked to complete a short questionnaire about their experience using a NightWatch around the leg. Also, participants are asked to record whether alarms from the NightWatch worn around the arm were true or false positives.
When researching the functionality of NightWatch around the leg, it is important to look at the entire target population that is currently using the NightWatch and for which it has been validated. Since the NightWatch has been clinically validated for children aged 4 years and older (Lazeron et al., 2022; van Westrhenen et al., 2023), and is widely used at home in children with seizures, it is highly relevant to include this group in this study. These are children who are already used to sleeping with a NightWatch around the arm every night, so it is expected that the temporary addition of a second module is only a minimal burden. If sleeping with a second module around the leg does prove to be too stressful for a child, parents will be instructed by the researchers to stop participation in the study.
E.M. Lemmen
Sterkselseweg 65
Heeze 5591 VE
Netherlands
040 2279 201
lemmene@kempenhaeghe.nl
E.M. Lemmen
Sterkselseweg 65
Heeze 5591 VE
Netherlands
040 2279 201
lemmene@kempenhaeghe.nl
Trial sites in the Netherlands
Listed location countries
Age
Inclusion criteria
- At least 1 major nocturnal seizure per week
- Already uses a NightWatch on the arm linked to the internet
- Living in the Netherlands
- At least 4 years old
Exclusion criteria
Unwilling to wear a second NightWatch around the leg
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
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 |
|---|---|
| Research portal | NL-009494 |