We hypothesize that VOC analysis by eNose is able to detect intra-individual changes in exhaled breath profiles and body odors of epilepsy patients prior to a seizure.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the diagnostic accuracy, including an ROC curve, sensitivity and
specificity, of exhaled breath analysis by eNose for seizure detection and
prediction in epileptic patients.
To determine the diagnostic accuracy of body odor analysis by eNose for seizure
detection and prediction in epileptic patients.
Secondary outcome
To determine the diagnostic accuracy of exhaled breath and body odor analysis
by eNose for the discrimination between different types of seizures.
To compare intra-individual temporal fluctuations in VOC profiles in
interictal, pre-ictal, ictal and postictal state.
Background summary
The unpredictability of seizures has a major impact on the quality of life of
epileptic patients as it often leads to injuries and limits performing ordinary
daily tasks and jobs. Over the past decades, efforts are ongoing to develop
devices that could detect and predict seizures that could be used in daily
lives of the patients. These devices could potentially prevent accidents and
improve outcomes by allowing early intervention.
Recent advances in the field of metabolomics have resulted in the development
of electronic noses (eNose) that are based on an array of sensors reacting to
the complete mixtures of volatile organic compounds (VOCs) in exhaled breath.
In a small pilot study, we were able to discriminate patients with epilepsy in
interictal state from healthy individuals based on the mixture of VOCs measured
in their exhaled breath.
Study objective
We hypothesize that VOC analysis by eNose is able to detect intra-individual
changes in exhaled breath profiles and body odors of epilepsy patients prior to
a seizure.
Study design
Single-centre pilot study with an observational cohort study design.
Study burden and risks
As this concerns observational research, no direct risk is involved with
participation in this study. Participation in this study does not affect the
subjects* regular care.
Achterweg 2
Heemstede 2103 SW
NL
Achterweg 2
Heemstede 2103 SW
NL
Listed location countries
Age
Inclusion criteria
>= 18 years of age
Admitted to SEIN for video-EEG recording
Diagnosed with epilepsy
High seizure frequency (1 or more per week), or admitted for multiple days of
video-EEG as part of epilepsy surgery track with tapering of anti-seizure
medication
Mentally competent and with no learning disabilities
Exclusion criteria
Recent (< 12 hours) intake of alcohol
Psychogenic Nonepileptic Seizures (PNES), without comorbidity of epilepsy or
with high level of doubt of epilepsy diagnosis
Unwillingness or inability to comply with the study protocol for any other
reason
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL73338.058.20 |