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Leg Epilepsy Guard Study - LEGS

Research on the use of NightWatch on the leg - Leg Epilepsy Guard Study (LEGS) - Leg Epilepsy Guard Study (LEGS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57506
Enrollment
20
Registered
2025-02-24
Start date
2025-06-02
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Interventions

Participants will wear a second NightWatch worn around their leg for 4 weeks.

Sponsors

Kempenhaeghe
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: At least 2 major nocturnal seizures per monthAlready uses a NightWatch on the arm linked to the internetLiving in the NetherlandsAt least 4 years old

Exclusion criteria

Exclusion criteria: Unwilling to wear a second NightWatch around the leg

Design outcomes

Primary

MeasureTime frame
The primary outcome measure of this study is whether the NightWatch on the leg detects the same seizures as the NightWatch on the arm.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Contacts

Public ContactJ.P. Dijk

Kempenhaeghe

dijkh@kempenhaeghe.nl040 2279 201

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)