Study of Patients with Electrical Status Epilepticus in Sleep

NCT06792396 | Recruiting

• 1 other identifier: 23/213
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Our aims are:

1. 1.To understand the diagnostic practices, treatment and long term management and outcomes for patients diagnosed with ESES locally.
2. 2.To establish a regional and national guideline for the diagnosis and management of patients with ESES.

Conditions

Electrical Status Epilepticus in Sleep

Outcome Measures

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.

  Over the past 10-15 years

Secondary Outcomes (5)

• Diagnosis criteria

  Over the last 10-15 years

• Treatments used

  Over the last 10-15 years

• Treatment response monitoring

  Over the last 10-15 years

• Duration of time

  Over the last 10-15 years

• Long term outcomes and clinical spectrum

  Over the last 10-15 years

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Within the East Suffolk and North Essex region

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• East Suffolk and North Essex NHS Foundation Trust: lead

Study Sites (1)

East Suffolk and North Essex NHS Foundation Trust

Colchester, United Kingdom

RECRUITING

Central Study Contacts

Thiloka Ratnaike

CONTACT

01473 704343; R&D@esneft.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 24, 2025
• Study Start: August 12, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)