Preliminary Testing of a Novel Device to Detect Epileptic Seizures
PTEpD
1 other identifier
observational
117
1 country
2
Brief Summary
Official statistics report around 1000 deaths due to epilepsy in the UK each year (Hanna et al 2002). Most of these deaths are un-witnessed and in many cases are believed to have been avoidable with timely assistance (Langan et al 2000). A major problem is detecting nocturnal seizures to allow body re-positioning, to maintain an open airway and to administer rescue medication. There are several seizure alarms commercially available but are often unreliable with many false alarms. The aim of this study is to investigate a novel seizure detection system with a unique algorithm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2015
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 4, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedStudy Start
First participant enrolled
January 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedMay 8, 2017
August 1, 2016
1.9 years
November 4, 2014
May 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reliable detection of epileptic seizures (Trigger level to be determined for total seizures)
Trigger level to be determined for total seizures
14 months
Secondary Outcomes (1)
Reliable detection of epileptic seizures (Trigger level to be determined for different types of seizures.)
14 months
Eligibility Criteria
Patients who are being admitted for electroencephalographic videotelemetry as part of their clinical management of their epilepsy will be invited to participate in the study.
You may qualify if:
- Frequent epileptic seizures 3 months and older Informed consent for participation
You may not qualify if:
- Infrequent seizures Attacks are of a non-epileptic nature Younger than 3 months Has an implantable device No informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- NHS Lothiancollaborator
Study Sites (2)
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Royal Hospital for Sick Children
Edinburgh, EH9 1LF, United Kingdom
Related Publications (2)
Hanna H.J, Black M, Sander J.W.S, Smithson W.H, Appleton R, Brown S, Fish D.R. The National Sentinel Clinical Audit of Epilepsy-Related Death- Death in the Shadows. The Stationery Office. The National Sentinel of Epilepsy-Related Deaths Report 2002 ISBN 0-117-02868-1
BACKGROUNDLangan Y, Nashef L, Sander JW. Sudden unexpected death in epilepsy: a series of witnessed deaths. J Neurol Neurosurg Psychiatry. 2000 Feb;68(2):211-3. doi: 10.1136/jnnp.68.2.211.
PMID: 10644790BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter AG Sandercock, BA,BM, BCh
University of Edinburgh
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2014
First Posted
November 7, 2014
Study Start
January 20, 2015
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
May 8, 2017
Record last verified: 2016-08