Pediatric Seizure Movement Bed Alarm

Completed

• Conditions: Sleep; Epilepsy; Seizures

• Registration Number: NCT01855178
• Lead Sponsor: Le Bonheur Children's Hospital

Brief Summary

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.

Detailed Description

For parents of children with epilepsy, seizures occurring in sleep are a major concern. This frequently leads to many nights of lost sleep for parents and also to unfavorable sleeping arrangements, especially for older children and adolescents. Sudden unexplained death in epilepsy patients (SUDEP) is also a major concern for both parents and neurology practitioners. Patients with epilepsy have increased risk of sudden unexplained death compared to the rest of the population. The risk of sudden death in epilepsy is estimated at 24 times the risk of the general population. Specific risk factors for sudden death have been evaluated and the most frequently reported risk factors include: nocturnal seizures, being in bed, and history of generalized tonic -clonic seizures. Interestingly, one case-control study observed a decreased risk of SUDEP with nighttime monitoring or supervision which raises the possibility that some cases of SUDEP may be preventable if another person is able to give assistance. This finding may indicate that some of these deaths may be preventable if a caregiver could be alerted to seizure activity. Use of "baby monitors", apnea monitors and pulse oximeters to monitor their children at night has been attempted by families; however, these devices are not specific to seizure activity and in the case of apnea monitors and pulse oximeters have frequent false alarms leading to further anxiety and sleep disturbance for families. Therefore, there is a need for a product that can reliably detect seizure activity without such frequent false positives as to interfere with sleep and functional life.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-16
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-02
• Last Update Posted: 2015-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• epilepsy

Exclusion Criteria

• non-epileptic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of nocturnal seizure bed alarm	5 years	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.

Secondary Outcome Measures

Name	Time	Method
Measure seizure types best detected using seizure bed alarm system	5 years	Determine which seizure types are best detected using the bed alarm system i.e. generalized tonic-clonic, tonic, focal clonic, complex-partial, seizure events.

Trial Locations

Locations (1)

LeBonheur Children's Medical Center; 🇺🇸 Memphis, Tennessee, United States