NCT05725174

Brief Summary

Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jan 2023Nov 2026

Study Start

First participant enrolled

January 30, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

2.7 years

First QC Date

February 2, 2023

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Distinguishing epileptic from non-epileptic seizures

    To distinguish epileptic from non-epileptic seizures with the detection of volatile organic compounds (VOCs) in breath and sebum samples.

    3 years

Interventions

Patients will have breath samples collected by blowing into a bag, and sweat samples collected by gauze. These samples will be collected at various timepoints whilst the patients are admitted on the ward.

Eligibility Criteria

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

People with a diagnosis of epileptic or non-epileptic seizures

You may qualify if:

  • Patients who have been admitted to either University College London's Queen's Square EEG-telemetry unit or Chalfont Centre for Epilepsy, for diagnosis of seizure events.
  • Patients aged 18 years or above

You may not qualify if:

  • Patients with active infection or who have taken antibiotics within 4 weeks
  • Patients on immunosuppressive medications
  • Patients with co-morbidities preventing breath collection
  • Patients unable to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chalfont Centre for Epilepsy

London, Buckinghamshire, SL9 0RJ, United Kingdom

RECRUITING

National Hospital for Neurology and Neurosurgery

London, London, WC1N 3BG, United Kingdom

RECRUITING

MeSH Terms

Conditions

EpilepsySeizures

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Matthew Walker, MB BChir FRCP

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleonora Lugara, PhD

CONTACT

Grace Luff, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 2, 2023

First Posted

February 13, 2023

Study Start

January 30, 2023

Primary Completion

October 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations