SeizuresPedsBedAlarmNCT01855178
Pediatric Seizure Movement Bed Alarm
An observational study of Seizures and Sleep, run by Le Bonheur Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 70 years
- What is being tested?
- Emfit Movement Monitor
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- epilepsy
Who cannot join
- non-epileptic
Trial locations and contacts
1 site in 1 country.
United States1 site
LeBonheur Children's Medical Center
Memphis, Tennessee, 38103
About this study
Official 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.
Read the 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.
- Being tested
- Emfit Movement Monitor
- Keywords
- nocturnal, epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emfit Movement MonitorDevice
Also called control unit D2090, under mattress sensor L-4060SL, Seat sensor L3030SL
Factory settings
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Bonheur Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W. Wheless, Le Bonheur Children's Hospital
- Investigators
- James W Wheless, MD, Principal investigator, LeBonheur Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01855178
- Sponsor's protocol ID
- 10-00895-XP
- Acronym
- PedsBedAlarm
- Status last verified
- Sep 2015
- First submitted
- 23 Feb 2012
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19100767
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Seizure Alarm: A Pilot Study to Establish Efficacy Parameters
- ClinicalTrials.gov ID
- NCT01855178
- Acronym / sponsor ID
- PedsBedAlarm / 10-00895-XP
- Keywords
- nocturnal, epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Le Bonheur Children's HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 16 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- epilepsy
Key exclusion criteria (1 listed)
- non-epileptic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emfit Movement MonitorAlso: control unit D2090, under mattress sensor L-4060SL, Seat sensor L3030SLFactory settings | Device | – |
Primary outcome
Efficacy of nocturnal seizure bed alarm
Time frame: 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.
1 secondary outcome
Measure seizure types best detected using seizure bed alarm system
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2015.
- Background: PubMed 19100767Rauhala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James W Wheless, MD principal investigator
LeBonheur Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and Sleep, run by Le Bonheur Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of nocturnal seizure bed alarm (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01855178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2015; AzTrials last refreshed its copy on 30 Oct 2026.