Epilepsy in ChildrenPROMISENCT03909984
Promoting Implementation of Seizure Detection Devices in Epilepsy Care
A study testing Nightwatch in people with Epilepsy in Children, run by Stichting Epilepsie Instellingen Nederland at 3 sites in Netherlands.
Trial summary
This is a multicenter home-based medical device intervention study, with prospective validation of the wearable seizure detection device (Nightwatch) and retrospective validation of remote sensors (video and audio detection) in children. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- Nightwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesNetherlands
- Study dates
- 26 Apr 2018to 8 Apr 2021
- Phase
- Interventional
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 4-16 years
- Diagnosis of refractory epilepsy with ≥1 major nocturnal seizure per week.
- Treated at one of the following epilepsy centers: SEIN, Kempenhaeghe or UMCU.
- Written informed consent by legal representatives (mostly parents) and also by the subject when aged ≥12 years and capable of signing informed consent.
Who cannot join
- Intensive non-epileptic movement patterns such as severe choreatiform movements, intensive sleep walking, or frequent night terrors (> 1/week).
- Minor motor seizures only, i.e. non-generalized or short (< 10 sec.) tonic seizures or isolated myoclonias that are self-limited and do not require intervention.
- Presence of a pacemaker or cardiac arrhythmias that may generate false alarms (e.g. supraventricular tachycardia).
- Inability to comply to the trial procedure.
- Skin characteristics (e.g. tattoo) that may affect photoplethysmography and thereby influence performance of the Nightwatch.
- Dependence on another SDD (e.g. Emfit or saturation monitor). Simultaneous use of a baby phone (or other types of microphones) is permitted.
- Subjects who are not sleeping alone in the bed (i.e. co-sleeping in the parents'/guardians' bed influences the remote SDD). Subjects and parents/guardians are not allowed to change their sleeping habits for the duration of the study only.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Stichting Epilepsie Instellingen Nederland (SEIN)
Heemstede, Achterweg 5, 2103 SW
Academic Center of Epileptology Kempenhaeghe
Heeze, 5591 VE
University Medical Center Utrecht
Utrecht, 3584 CX
About this study
Official title: Promoting Implementation of Seizure Detection Devices in Epilepsy Care: the PROMISE Study
This is a multicenter home-based medical device intervention study, with prospective validation of the wearable seizure detection device (Nightwatch) and retrospective validation of remote sensors (video and audio detection) in children. The investigators will also perform a feasibility and utility analysis of Nightwatch.
Read the detailed description
Various remote and wearable sensor devices have become available for the detection of potentially dangerous seizures, with limited impact on epilepsy care so far. Both the investigator's remote and wearable seizure detection devices (SDDs) have been extensively tested and proven highly sensitive. Yet the home performance in children, an important target population, had been insufficiently studied.
Objective: 1. To test the performance of the wearable SDD (Nightwatch) prospectively and the remote SDD (automated video and audio analysis) retrospectively in children in a family home setting. 2. To assess the feasibility, cost-effectiveness and cost-utility of Nightwatch in children.
Study design: A multicenter home-based medical device intervention study with prospective validation of our wearable SDD.
Study population: 60 children (ages 4-16 years) with refractory epilepsy (≥1 major nocturnal seizure per week) recruited from the outpatient clinics of one of the participating epilepsy centers (Stichting Epilepsie instellingen Nederland (SEIN), Academic Centre of Epileptology Kempenhaeghe (Kempenhaeghe), University Medical Center Utrecht (UMCU)).
Intervention: Phase I: Two months of baseline (usual care); Phase 2: Two months of nocturnal seizure monitoring at home, using Nightwatch and the remote SDD.
Main study parameters/endpoints: The diagnostic performance of Nightwatch and the remote SDD algorithms, i.e. sensitivity, positive predictive value, false alarm rate and % time with uninterrupted signal output. The investigators will evaluate feasibility of Nightwatch through surveys on quality of life, sleep, parental strain, interviews with parents/guardians and neurologists, and a value sensitive design group session. The investigators will also perform a cost-effectiveness and cost-utility analysis by medical consumption and costs questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Implementing SDDs will not pose any direct or substantial risk. Study participation can be a burden though, due to impact of the devices on privacy, number of false alarms and time spent on the questionnaires and interviews. Application of the SDDs, however, might offer better insight into the actual number of nocturnal seizures in a child, change in medical management and facilitate appropriate interventions in major motor seizures. If reliable, SDDs may improve the night rest of both patient and parents/guardians.
- Conditions
- Epilepsy in Children
- Being tested
- Nightwatch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NightwatchDevice
Also called Video and audio detection
Nocturnal monitoring for 2 months with three different seizure detection devices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All participants will be monitored for 2 months. Receives: Device: Nightwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance Nightwatch - sensitivity
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of sensitivity.
Measured: Monitoring period of 2 months per participant.
Diagnostic performance Nightwatch - positive predictive value
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of positive predictive value.
Measured: Monitoring period of 2 months per participant.
Diagnostic performance Nightwatch - false alarm rate
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of false alarm rate.
Measured: Monitoring period of 2 months per participant.
Diagnostic performance Nightwatch - % time with uninterrupted signal
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of % of time with uninterrupted signal output.
Measured: Monitoring period of 2 months per participant.
Secondary outcomes (10)
Diagnostic performance of video and audio detection - sensitivity
Diagnostic performance of our remote seizure detection devices (video and audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of sensitivity.
Measured: Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - positive predictive value
Diagnostic performance of our remote seizure detection devices (video, audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of positive predictive value.
Measured: Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - false alarm rate
Diagnostic performance of our remote seizure detection devices (video, audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of false alarm rate.
Measured: Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - % time with uninterrupted signal output.
Diagnostic performance of our remote seizure detection devices (video, audio) to detect major nocturnal motor seizures in children at home, measured retrospectively by means of % time with uninterrupted signal output.
Measured: Monitoring period of 2 months per participant.
Feasibility of Nightwatch will be examined in an interview with parents/guardians, focussing on different aspects of the device.
Feasibility of Nightwatch with a mixed methods approach focusing on Acceptability, Demand, Implementation, Practicality, Expansion, Limited-efficacy testing, impact of the SDD on parents/guardians with children (interview).
Measured: 4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of Caregiver Strain Index (CSI).
Effect of Nightwatch on parental stress, with a stress questionnaire (CSI), containing 13 questions about stress with 'yes/no' answers.
11-13 tims 'yes' indicates high level of stress, 7-10 times 'yes' indicates medium level of stress and 0-6 times 'yes' means low level of stress.
Measured: 4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of Pittsburgh Sleep Quality Index (PSQI).
Effect of Nightwatch on parental sleep with a sleep questionnaire (PSQI), containing 10 questions about sleep, with scales from 1-4 to indicate how often parents/guardians experience certain sleep problems.
Measured: 4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of the Quality of Life questionnaire: EQ-5D-5L
Effect of Nightwatch on parental quality of life, with a QoL questionnaire (EQ-5D-5L), containing 5 questions about the person's health with a 1-5 scale indicating the severity of a certain health problem and a 0-100 rating scale of their health.
Measured: 4 month period (2 months usual care + 2 months monitoring)
Cost-effectiveness analysis of Nightwatch
Economic evaluation from a societal prospective of Nightwatch involving a cost-effectiveness analysis (CEA).
Measured: 4 month period (2 months usual care + 2 months monitoring)
Cost-utility analysis of Nightwatch
Economic evaluation from a societal prospective of Nightwatch involving a cost- a cost-utility analysis (CUA).
Measured: 4 month period (2 months usual care + 2 months monitoring)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start26 Apr 2018
- Primary completion8 Apr 2021
- Study completion8 Apr 2021
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 Epilepsy in ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 1: Usual care (2 months), Phase 2: Intervention with monitoring true different devices (2 months), Phase 3: Optional phase with continued use of Nightwatch or tailoring.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stichting Epilepsie Instellingen Nederland
- Sponsor type
- University, hospital or other
- Collaborators
- Kempenhaeghe Academic Center for Epileptology and Residential Epilepsy Care, UMC Utrecht
- Responsible party
- Sponsor
- Investigators
- Anouk van Westrhenen, MD, Principal investigator, Stichting Epilepsie Instellingen NederlandRoland D Thijs, MD, PhD, Study director, Stichting Epilepsie Instellingen Nederland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909984
- Sponsor's protocol ID
- NL62995.041.17
- Acronym
- PROMISE
- Status last verified
- Aug 2021
- First submitted
- 8 Mar 2018
- Last updated
- 18 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Principal investigators will share necessary information on participants and enrollment.
Publications
van Westrhenen A, Lazeron RHC, van Dijk JP, Leijten FSS, Thijs RD; Dutch TeleEpilepsy Consortium. Multimodal nocturnal seizure detection in children with epilepsy: A prospective, multicenter, long-term, in-home trial. Epilepsia. 2023 Aug;64(8):2137-2152. doi: 10.1111/epi.17654. Epub 2023 Jun 14.
PubMed 37195144
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Implementation of Seizure Detection Devices in Epilepsy Care: the PROMISE Study
- ClinicalTrials.gov ID
- NCT03909984
- Acronym / sponsor ID
- PROMISE / NL62995.041.17
- Conditions
- Epilepsy in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stichting Epilepsie Instellingen NederlandUniversity, hospital or other
- Collaborators
- Kempenhaeghe Academic Center for Epileptology and Residential Epilepsy Care, UMC Utrecht
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 8 Apr 2021 (actual)
- Study completion
- 8 Apr 2021 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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.
This is a multicenter home-based medical device intervention study, with prospective validation of the wearable seizure detection device (Nightwatch) and retrospective validation of remote sensors (video and audio detection) in children. The investigators will also perform a feasibility and utility analysis of Nightwatch.
Detailed description
Various remote and wearable sensor devices have become available for the detection of potentially dangerous seizures, with limited impact on epilepsy care so far. Both the investigator's remote and wearable seizure detection devices (SDDs) have been extensively tested and proven highly sensitive. Yet the home performance in children, an important target population, had been insufficiently studied.
Objective: 1. To test the performance of the wearable SDD (Nightwatch) prospectively and the remote SDD (automated video and audio analysis) retrospectively in children in a family home setting. 2. To assess the feasibility, cost-effectiveness and cost-utility of Nightwatch in children.
Study design: A multicenter home-based medical device intervention study with prospective validation of our wearable SDD.
Study population: 60 children (ages 4-16 years) with refractory epilepsy (≥1 major nocturnal seizure per week) recruited from the outpatient clinics of one of the participating epilepsy centers (Stichting Epilepsie instellingen Nederland (SEIN), Academic Centre of Epileptology Kempenhaeghe (Kempenhaeghe), University Medical Center Utrecht (UMCU)).
Intervention: Phase I: Two months of baseline (usual care); Phase 2: Two months of nocturnal seizure monitoring at home, using Nightwatch and the remote SDD.
Main study parameters/endpoints: The diagnostic performance of Nightwatch and the remote SDD algorithms, i.e. sensitivity, positive predictive value, false alarm rate and % time with uninterrupted signal output. The investigators will evaluate feasibility of Nightwatch through surveys on quality of life, sleep, parental strain, interviews with parents/guardians and neurologists, and a value sensitive design group session. The investigators will also perform a cost-effectiveness and cost-utility analysis by medical consumption and costs questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Implementing SDDs will not pose any direct or substantial risk. Study participation can be a burden though, due to impact of the devices on privacy, number of false alarms and time spent on the questionnaires and interviews. Application of the SDDs, however, might offer better insight into the actual number of nocturnal seizures in a child, change in medical management and facilitate appropriate interventions in major motor seizures. If reliable, SDDs may improve the night rest of both patient and parents/guardians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1: Usual care (2 months), Phase 2: Intervention with monitoring true different devices (2 months), Phase 3: Optional phase with continued use of Nightwatch or tailoring.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: NightwatchAll participants will be monitored for 2 months. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 4-16 years
- Diagnosis of refractory epilepsy with ≥1 major nocturnal seizure per week.
- Treated at one of the following epilepsy centers: SEIN, Kempenhaeghe or UMCU.
- Written informed consent by legal representatives (mostly parents) and also by the subject when aged ≥12 years and capable of signing informed consent.
Key exclusion criteria (7 listed)
- Intensive non-epileptic movement patterns such as severe choreatiform movements, intensive sleep walking, or frequent night terrors (> 1/week).
- Minor motor seizures only, i.e. non-generalized or short (< 10 sec.) tonic seizures or isolated myoclonias that are self-limited and do not require intervention.
- Presence of a pacemaker or cardiac arrhythmias that may generate false alarms (e.g. supraventricular tachycardia).
- Inability to comply to the trial procedure.
- Skin characteristics (e.g. tattoo) that may affect photoplethysmography and thereby influence performance of the Nightwatch.
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 |
|---|---|---|
| NightwatchAlso: Video and audio detectionNocturnal monitoring for 2 months with three different seizure detection devices. | Device | Intervention |
Primary outcome
Diagnostic performance Nightwatch - sensitivity
Time frame: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of sensitivity.
Diagnostic performance Nightwatch - positive predictive value
Time frame: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of positive predictive value.
Diagnostic performance Nightwatch - false alarm rate
Time frame: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of false alarm rate.
Diagnostic performance Nightwatch - % time with uninterrupted signal
Time frame: Monitoring period of 2 months per participant.
Performance of Nightwatch to detect major nocturnal motor seizures in children at home, measured prospectively by means of % of time with uninterrupted signal output.
10 secondary outcomes
Diagnostic performance of video and audio detection - sensitivity
Time frame: Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - positive predictive value
Time frame: Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - false alarm rate
Time frame: Monitoring period of 2 months per participant.
Diagnostic performance of video and audio detection - % time with uninterrupted signal output.
Time frame: Monitoring period of 2 months per participant.
Feasibility of Nightwatch will be examined in an interview with parents/guardians, focussing on different aspects of the device.
Time frame: 4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of Caregiver Strain Index (CSI).
Time frame: 4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of Pittsburgh Sleep Quality Index (PSQI).
Time frame: 4 month period (2 months usual care + 2 months monitoring)
Feasibility of Nightwatch by means of the Quality of Life questionnaire: EQ-5D-5L
Time frame: 4 month period (2 months usual care + 2 months monitoring)
Cost-effectiveness analysis of Nightwatch
Time frame: 4 month period (2 months usual care + 2 months monitoring)
Cost-utility analysis of Nightwatch
Time frame: 4 month period (2 months usual care + 2 months monitoring)
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 18 Aug 2021.
- Derived from this study: PubMed 37195144van Westrhenen A, Lazeron RHC, van Dijk JP, Leijten FSS, Thijs RD; Dutch TeleEpilepsy Consortium. Multimodal nocturnal seizure detection in children with epilepsy: A prospective, multicenter, long-term, in-home trial. Epilepsia. 2023 Aug;64(8):2137-2152. doi: 10.1111/epi.17654. Epub 2023 Jun 14.
- Individual participant dataSharing planned: Yes. Principal investigators will share necessary information on participants and enrollment.
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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.
Anouk van Westrhenen, MD principal investigator
Stichting Epilepsie Instellingen Nederland
Roland D Thijs, MD, PhD study director
Stichting Epilepsie Instellingen Nederland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nightwatch in people with Epilepsy in Children, run by Stichting Epilepsie Instellingen Nederland at 3 sites in Netherlands.
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 4 inclusion and 7 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 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Diagnostic performance Nightwatch - sensitivity (time frame: Monitoring period of 2 months per participant.). The study lists 4 primary outcomes in all. 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 NCT03909984, 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 18 Aug 2021.