NCT06180538

Brief Summary

The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

December 12, 2023

Last Update Submit

December 12, 2023

Conditions

Epilepsy

Keywords

wearable device

Outcome Measures

Primary Outcomes (1)

  • Quality of Life in Epilepsy Inventory (QOLIE-31)

    Prior to admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from the Epilepsy Monitoring Unit in Beaumont Hospital who have a history of tonic-clonic seizures

You may qualify if:

  • The participant is over the age of 18
  • The participant has access to a smartphone
  • The participant has a history of generalised tonic-clonic seizures in the past year

You may not qualify if:

  • The participant lacks capacity to give informed consent (e.g. has intellectual disability)
  • The participant is a paediatric patient (aged below 18)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

John David Damalerio

CONTACT

+353 83 017 0056johndaviddamale22@rcsi.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2023

First Posted

December 22, 2023

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

December 22, 2023

Record last verified: 2023-12