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Promoting implementation of seizure detection devices in epilepsy care: the PROMISE study

Promoting implementation of seizure detection devices in epilepsy care: the PROMISE study - the PROMISE study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50690
Enrollment
60
Registered
2018-02-23
Start date
2018-04-26
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

convulsions Epileptic seizures

Interventions

None listed

Sponsors

Stichting Epilepsie Instellingen Nederland
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 (

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)