Pediatric Seizure Movement Bed Alarm (PedsBedAlarm)

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Sleep; Seizures
• Intervention / Treatment: Device: Emfit Movement Monitor

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 Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • LeBonheur Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 200 children and young adults will be enrolled in the study. Patients will be recruited from the population of children and young adults being admitted to the Epilepsy Monitoring Unit at LeBonheur Children's Hospital for evaluation of ongoing seizure disorders.

Description

Inclusion Criteria:

• epilepsy

Exclusion Criteria:

• non-epileptic

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Le Bonheur Children's Hospital
• Investigators: Principal Investigator: James W Wheless, MD, LeBonheur Children's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Estimate): September 4, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: epilepsy; nocturnal
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: 10-00895-XP