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

Completed

Conditions: convulsions
Epileptic seizures
10039911

Registration Number: NL-OMON50690

Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will measure the performance of the Nightwatch and the video & audio<br /><br>algorithms through calculation of sensitivity, positive predictive value, false<br /><br>alarm rate and % time with valid signal allowing proper detection.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will evaluate feasibility of the Nightwatch through surveys on quality of<br /><br>life, sleep, pearental strain, and medical consumption and costs questionnaires<br /><br>and interviews with parent(s)/representative(s). </p><br>