Electrical Status Epilepticus in SleepSPESESNCT06792396
Study of Patients with Electrical Status Epilepticus in Sleep
An observational study of Electrical Status Epilepticus in Sleep, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Our aims are: 1. To understand the diagnostic practices, treatment and long term management and outcomes for patients diagnosed with ESES locally. 2. To establish a regional and national guideline for the diagnosis and management of patients with ESES. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Electrical Status Epilepticus in Sleep
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2024to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Within the East Suffolk and North Essex region
Who may be able to join
- Any Paediatric patient (up to 16 years old) who has been managed for electrical status epilepticus in sleep or developmental and/or epileptic encephalopathy with spike-wave activation in sleep, by clinicians at East Suffolk and North Essex NHS Foundation Trust, within the last 15 years.
- Patients meeting criteria 1) with available electronic health records.
Who cannot join
- Any Paediatric patient (up to 16 years old) with epilepsy managed by clinicians at East Suffolk and North Essex NHS Foundation Trust, where the diagnosis of electrical status epilepticus in sleep or developmental and/or epileptic encephalopathy with spike-wave activation in sleep was not confirmed.
- Patients without electronic health record availability.
- Patients over 16 years old.
- Patients who have opted out of data use as per national opt out policy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
East Suffolk and North Essex NHS Foundation Trust
Colchester
Thiloka Ratnaike, 01473 704343, R&D@esneft.nhs.uk
About this study
Official title: Study to Understand the Diagnostic Measures, Management Options and Long Term Outcomes in a Local Cohort of Patients with Electrical Status Epilepticus in Sleep, Also Known As a Developmental And/or Epileptic Encephalopathy with Spike-Wave Activation in Sleep
Our aims are:
- To understand the diagnostic practices, treatment and long term management and outcomes for patients diagnosed with ESES locally.
- To establish a regional and national guideline for the diagnosis and management of patients with ESES.
The secondary questions that can be addressed with this case series review include the variability of clinical care given to patients with this condition, and for example, the duration of time it takes to obtain diagnostic tests and assessments by psychologists.
Read the detailed description
The Paediatric consultants specialising in epilepsy and neurodisability at ESNEFT that are on the delegation log will identify patients who have been diagnosed with ESES since 2010.
This list of patients will be pseudo-anonymised (by tagging patients with a random identification number). Patient identifiable data including local hospital identification number and date of birth will be collected on the local case record form (CRF) to enable retrospective data collection. The hospital number will remain within the Trust, meaning only the local NHS staff responsible for care have access to personal identifying information.
No personal data will be leaving ESNEFT. Patients will be identified by their treating clinicians who are aware of their diagnoses and will list the patient hospital number in a password-protected spreadsheet. The list will be pseudo-anonymised by assigning a random number to the case, and anonymised data will be then gathered in the data collection tool. This ensures patient confidentiality. We will use two separate spreadsheets, one documenting the patient's hospital number and their assigned study number. This spreadsheet will not contain any other identifiable patient details (i.e. patient name, age, date of birth etc). A separate spreadsheet will contain patient study numbers only with medical history information relevant to the study. Both will be password protected secured on the NHS site. All data will be entered promptly and frequently cleaned.
The patient electronic patient records will be mined for information regarding age at onset, symptoms at onset, developmental issues, ongoing clinical history- recorded as Human Phenotype Ontology terms, diagnostic tests, duration of time till diagnostic tests such as electroencephalography in sleep or genetic tests undertaken, and duration of time till neuropsychology assessments (if any) undertaken. We will also record the underlying cause for ESES (where available), whether the patient has been discharged from ongoing follow-up and if there are ongoing physical or neuropsychological issues, at their current age. This information will be collected using a data collection tool, which will be an excel spreadsheet.
The anonymised dataset will be analysed by the research team. We will involve patient and family groups in the review of documents prior to dissemination of research findings.
- Conditions
- Electrical Status Epilepticus in Sleep
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of an evidence-based guideline
The primary outcome measure for the study is the creation of an evidence-based guideline using clinical experience of managing patients with electrical status epilepticus in sleep.
Measured: Over the past 10-15 years
Secondary outcomes (5)
Diagnosis criteria
Diagnostic criteria used when patients were given a diagnosis of electrical status epilepticus in sleep (ESES)
Measured: Over the last 10-15 years
Treatments used
Treatments used prior to and after diagnosis of ESES
Measured: Over the last 10-15 years
Treatment response monitoring
How treatment response was monitored
Measured: Over the last 10-15 years
Duration of time
Duration of time taken to assess a patient using electroencephalography and neuropsychological tests
Measured: Over the last 10-15 years
Long term outcomes and clinical spectrum
Long term outcomes and clinical spectrum associated with ESES
Measured: Over the last 10-15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start12 Aug 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical Status Epilepticus in SleepStudies 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Suffolk and North Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792396
- Sponsor's protocol ID
- 23/213
- Acronym
- SPESES
- Status last verified
- Jan 2025
- First submitted
- 30 Dec 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Understand the Diagnostic Measures, Management Options and Long Term Outcomes in a Local Cohort of Patients with Electrical Status Epilepticus in Sleep, Also Known As a Developmental And/or Epileptic Encephalopathy with Spike-Wave Activation in Sleep
- ClinicalTrials.gov ID
- NCT06792396
- Acronym / sponsor ID
- SPESES / 23/213
- Conditions
- Electrical Status Epilepticus in Sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- East Suffolk and North Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 24 Jan 2025 (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.
Our aims are:
- To understand the diagnostic practices, treatment and long term management and outcomes for patients diagnosed with ESES locally.
- To establish a regional and national guideline for the diagnosis and management of patients with ESES.
The secondary questions that can be addressed with this case series review include the variability of clinical care given to patients with this condition, and for example, the duration of time it takes to obtain diagnostic tests and assessments by psychologists.
Detailed description
The Paediatric consultants specialising in epilepsy and neurodisability at ESNEFT that are on the delegation log will identify patients who have been diagnosed with ESES since 2010.
This list of patients will be pseudo-anonymised (by tagging patients with a random identification number). Patient identifiable data including local hospital identification number and date of birth will be collected on the local case record form (CRF) to enable retrospective data collection. The hospital number will remain within the Trust, meaning only the local NHS staff responsible for care have access to personal identifying information.
No personal data will be leaving ESNEFT. Patients will be identified by their treating clinicians who are aware of their diagnoses and will list the patient hospital number in a password-protected spreadsheet. The list will be pseudo-anonymised by assigning a random number to the case, and anonymised data will be then gathered in the data collection tool. This ensures patient confidentiality. We will use two separate spreadsheets, one documenting the patient's hospital number and their assigned study number. This spreadsheet will not contain any other identifiable patient details (i.e. patient name, age, date of birth etc). A separate spreadsheet will contain patient study numbers only with medical history information relevant to the study. Both will be password protected secured on the NHS site. All data will be entered promptly and frequently cleaned.
The patient electronic patient records will be mined for information regarding age at onset, symptoms at onset, developmental issues, ongoing clinical history- recorded as Human Phenotype Ontology terms, diagnostic tests, duration of time till diagnostic tests such as electroencephalography in sleep or genetic tests undertaken, and duration of time till neuropsychology assessments (if any) undertaken. We will also record the underlying cause for ESES (where available), whether the patient has been discharged from ongoing follow-up and if there are ongoing physical or neuropsychological issues, at their current age. This information will be collected using a data collection tool, which will be an excel spreadsheet.
The anonymised dataset will be analysed by the research team. We will involve patient and family groups in the review of documents prior to dissemination of research findings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Within the East Suffolk and North Essex region
Key inclusion criteria (2 listed)
- Any Paediatric patient (up to 16 years old) who has been managed for electrical status epilepticus in sleep or developmental and/or epileptic encephalopathy with spike-wave activation in sleep, by clinicians at East Suffolk and North Essex NHS Foundation Trust, within the last 15 years.
- Patients meeting criteria 1) with available electronic health records.
Key exclusion criteria (4 listed)
- Any Paediatric patient (up to 16 years old) with epilepsy managed by clinicians at East Suffolk and North Essex NHS Foundation Trust, where the diagnosis of electrical status epilepticus in sleep or developmental and/or epileptic encephalopathy with spike-wave activation in sleep was not confirmed.
- Patients without electronic health record availability.
- Patients over 16 years old.
- Patients who have opted out of data use as per national opt out policy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of an evidence-based guideline
Time frame: Over the past 10-15 years
The primary outcome measure for the study is the creation of an evidence-based guideline using clinical experience of managing patients with electrical status epilepticus in sleep.
5 secondary outcomes
Diagnosis criteria
Time frame: Over the last 10-15 years
Treatments used
Time frame: Over the last 10-15 years
Treatment response monitoring
Time frame: Over the last 10-15 years
Duration of time
Time frame: Over the last 10-15 years
Long term outcomes and clinical spectrum
Time frame: Over the last 10-15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Electrical Status Epilepticus in Sleep
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Melatonin for the Treatment of DEE-SWAS
CSWS, Developmental and/or Epileptic Encephalopathies
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.
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 Electrical Status Epilepticus in Sleep, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jan 2025. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thiloka Ratnaike (01473 704343, R&D@esneft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Creation of an evidence-based guideline (time frame: Over the past 10-15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2025.