To assess the provoking effect of partial sleep deprivation on paroxysmal neurological events in a EMU setting, in people with possible epileptic seizures.
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in number of participants in which a habitual event occurred
during the EMU recording between the two study groups.
Secondary outcome
- identification of clinical characteristics that are associated with the
probability that sleep deprivation can provoke clinical events (etiology of
events, specific type of epilepsy/seizures).
- The difference between the two intervention groups concerning the time to the
recording of the first habitual paroxysmal neurological event and the
wake/sleep state and time of the day in which the events occurs.
- The difference between the two intervention groups concerning the occurrence
of the following adverse events: generalized tonic-clonic seizures, seizure
clustering.
Background summary
One diagnostic goal in long-term video-EEG monitoring at an EMU setting is to
determine whether paroxysmal neurological events are of epileptic or
non-epileptic origin. In order to answer such a diagnostic question, the
recording of an actual event is required. Although (partial) sleep deprivation
is very often used in tertiary epilepsy centres aiming to provoke clinical
events, it has never been investigated whether this actually increases event
frequency in either epileptic seizures or non-epileptic (psychogenic) attacks.
Study objective
To assess the provoking effect of partial sleep deprivation on paroxysmal
neurological events in a EMU setting, in people with possible epileptic
seizures.
Study design
Randomized, open
Intervention
partial sleep deprivation
Study burden and risks
As partial sleep deprivation is already used in longterm monitoring at the EMU,
no additional burden or risks are expected. The only extra burden is a
questionnare with 5 questions.
achterweg 5
Heemstede 2103SW
NL
achterweg 5
Heemstede 2103SW
NL
Listed location countries
Age
Inclusion criteria
People above the age of 18 years with paroxismal neurological events, with a clinical suspicion of (focal) epilepsy.
Exclusion criteria
Mentally disabled people
Most likely diagnosis of idiopathic generalized epilepsy
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL61889.058.17 |