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RecruitingNCT06792396SPESESUpdated Jan 24, 2025

Study of Patients with Electrical Status Epilepticus in Sleep

An observational study in Electrical Status Epilepticus in Sleep, sponsored by East Suffolk and North Essex NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2025-01-24.

Sponsored by East Suffolk and North Essex NHS Foundation Trust · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20
Ages
1 Year to 16 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Electrical Status Epilepticus in Sleep

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03

In context

Status Epilepticus

126 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.

This study's planned enrollment of 20 is below the median of 146 across 44 observational studies indexed under Status Epilepticus.

Browse Status Epilepticus studies →

Lead sponsor

East Suffolk and North Essex NHS Foundation Trust is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Within the East Suffolk and North Essex region

Inclusion criteria

  1. 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.
  2. Patients meeting criteria 1) with available electronic health records.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patients without electronic health record availability.
  3. Patients over 16 years old.
  4. Patients who have opted out of data use as per national opt out policy.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Over the past 10-15 years

Secondary outcomes

  1. Diagnosis criteria

    Diagnostic criteria used when patients were given a diagnosis of electrical status epilepticus in sleep (ESES)

    Time frame: Over the last 10-15 years

  2. Treatments used

    Treatments used prior to and after diagnosis of ESES

    Time frame: Over the last 10-15 years

  3. Treatment response monitoring

    How treatment response was monitored

    Time frame: Over the last 10-15 years

  4. Duration of time

    Duration of time taken to assess a patient using electroencephalography and neuropsychological tests

    Time frame: Over the last 10-15 years

  5. Long term outcomes and clinical spectrum

    Long term outcomes and clinical spectrum associated with ESES

    Time frame: Over the last 10-15 years

07

Study locations

1 of 1 sites recruiting
  • East Suffolk and North Essex NHS Foundation Trust
    Colchester, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06792396
Lead sponsor
East Suffolk and North Essex NHS Foundation Trust
Responsible party
Sponsor
First posted
Jan 24, 2025
Start date
Aug 12, 2024
Primary completion
Mar 2025 (estimated)
Completion
Mar 2025 (estimated)
Last update
Jan 24, 2025

Study contacts

Thiloka Ratnaike
Contact
R&D@esneft.nhs.uk
01473 704343

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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