Epilepsy Clinical Trial
— PedsBedAlarmOfficial title:
Pediatric Seizure Alarm: A Pilot Study to Establish Efficacy Parameters
Nocturnal seizure and Sudden unexplained death in epilepsy patients (SUDEP) are major concerns for parents and creates anxiety and poor sleep conditions for many families dealing with epilepsy. An accurate and reliable system for alerting parents to ongoing seizure activity could make a substantial impact in quality of life and possibly reduce the mortality of epilepsy. No previous studies in the pediatric population have been performed to evaluate this type of monitoring for seizure activity. This is one of the most common questions parents ask in clinic, "Are there any alarms that can tell me when my child is having a seizure at night?" Currently the answer is no. This study has the capability to give us data that may change this answer to yes.
Status | Completed |
Enrollment | 136 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 70 Years |
Eligibility |
Inclusion Criteria: - epilepsy Exclusion Criteria: - non-epileptic |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | LeBonheur Children's Medical Center | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Le Bonheur Children's Hospital |
United States,
Rauhala E, Virkkala J, Himanen SL. Periodic limb movement screening as an additional feature of Emfit sensor in sleep-disordered breathing studies. J Neurosci Methods. 2009 Mar 30;178(1):157-61. doi: 10.1016/j.jneumeth.2008.11.019. Epub 2008 Dec 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of nocturnal seizure bed alarm | Measure the occurrence rate of false alarms. Determine if setting parameters for detection can be established according to age and body weight of child/adult. | 5 years | No |
Secondary | Measure seizure types best detected using seizure bed alarm system | Determine which seizure types are best detected using the bed alarm system i.e. generalized tonic-clonic, tonic, focal clonic, complex-partial, seizure events. | 5 years | No |
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