Pediatric Seizure Movement Bed Alarm

Epilepsy Clinical Trial

— PedsBedAlarm  

Official title:

Pediatric Seizure Alarm: A Pilot Study to Establish Efficacy Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01855178
• Other study ID #: 10-00895-XP
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: September 2, 2015
• Start date: October 2010
• Est. completion date: June 2015

Study information

• Verified date: September 2015
• Source: Le Bonheur Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy
• Seizures
• Sleep

Intervention

Device:
• Emfit Movement Monitor
Factory settings

Locations

Country	Name	City	State
United States	LeBonheur Children's Medical Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Le Bonheur Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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