To evaluate if an event (changes of heart frequency) related video-observation is a more efficient diagnostic procedure for parasomnias.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reliability, sensitivity and specificity of the detection of parasomnic events.
Secondary outcome
Comparison of event related detection with an one night polysomnography
combined with videorecording; value of SCID and MMIP tests for the mental
background of parasomnia.
Background summary
Parasomnia (attacks with abnormal behavior during sleep) can only be found by
polysomnography in combination with video recordings. This is a complicated
procedure that can be applied only during one or two nights. Parasomnic attacks
are often infrequent, so the current procedure is nog sufficient. In this
project we try to record parasomnic events more effectively.
Study objective
To evaluate if an event (changes of heart frequency) related video-observation
is a more efficient diagnostic procedure for parasomnias.
Study design
An open explorative study during which in ten persons with parasomnia a
'seizure detector' is applied during five nights. This detector sends an alarm
if heart rate is specifically accelerated. Digital video-information around the
alarms is stored, inspected and compared with a traditional polysomnography
including video recording. We also obtain some questionnaires / interviews to
get an impression of the mental situation of the persons. This is important for
the final diagnosis of the type of parasomnia.
Study burden and risks
The burden of the study is a five-nights long hospital admission with nocturnal
videorecording; every night three electrodes are applied for the detection of
heart rate; during one night a polysomnography will be carried out (with
multiple electrodes and sensors); finally the various questionnaires /
interviews are a burden. The risks are small (skin reactions on the electrodes,
reactions on privacy disturbances).
Postbus 61
5590 AB
Nederland
Postbus 61
5590 AB
Nederland
Listed location countries
Age
Inclusion criteria
between 18 and 60 years of age
a body mass index between 18 and 30
suffering from NREM 3-4 and/or REM parasomnia
minimal parasomnia frequency: 2 / week
no acute behavioral problems, except as a part of RBD
no acute intercurrent somatic disease that may interfere with study results
informed consent form signed
adult
Exclusion criteria
epilepsy
major or significant internal or neurological that interfere with teh measurements
ESS score > 10/24
fast progressing neurological and / or systematic disorder
pregnancy
drugs or pacemakers that significantly influence hart rate
inability to comply with the trial procedure
inability to tolerate ECG electrodes
presence of manifest psychiatric disorders
below normal intelligence
Design
Recruitment
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 | NL12210.068.06 |