Sleep Medicine Center Kempenhaeghe has a unique opportunity to combine clinical PSG with different advanced non-invasive sleep monitoring techniques as mentioned in the former paragraph. In the center, data are currently obtained in a cohort of…
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To verify the snoring detection audio system in healthy subjects. To validate
the snoring detection audio system in healthy subjects to see whether it is
possible to distinguish healthy snoring from (sleep)disorder related snoring
obtained in a prior study.
Secondary outcome
To validate the different non-invasive advanced sleep monitoring techniques
against the gold standard polysomnography (PSG) for healthy participants. To
validate the different non-invasive advanced sleep monitoring techniques
compared to the performance in patients with various sleep disorders.
Background summary
Diagnoses for most sleep disorders are made based on a combination of the
subjects sleep history and sleep recordings based on polysomnography (PSG). The
complex setup for PSG requires patients to sleep in an unfamiliar environment
with many sensors attached to their head and body. New technologies are being
developed, with the potential to improve sleep monitoring, inclusnig wearable
sensing technology, acoustic signal analysis (such as snoring sounds) and
camera based vital signs measurements. These advanced techniques have in common
that they are easy to use over longer periods of time and (for some of them)
applicable in the home situation.
These promising techniques are developed and tested in controlled laboratory
settings and in clinical settings on patients. However, test data in clinical
settings with healthy subjects is limited. For proper development of these
techniques, a clinical validation of these applications in healthy participants
is essential, taking into account the normal variations in sleep in the
population.
Study objective
Sleep Medicine Center Kempenhaeghe has a unique opportunity to combine clinical
PSG with different advanced non-invasive sleep monitoring techniques as
mentioned in the former paragraph. In the center, data are currently obtained
in a cohort of patients with sleep disorders (the SOMNIA Study, METC N16.074).
Here, we aim to build a database containing PSG and non-invasive sleep
monitoring data of healthy participants. The acquired database will be used to
validate the individual new techniques and obtain normative data from the
healthy population. Finally, these data are important to determine the
specificity of new diagnostic methods in the future.
Study design
Observational study, comparing new non-obtrusive sleep monitoring technologies
against the current gold standard (polysomnography)
Study burden and risks
Burden is limited to spending one night in the sleep lab, undergoing a standard
sleep recording (PSG) together with the non-obtrusive new technologies. The PSG
will not be assessed by a clinician to actively look for signs of clinical
pathology. However, it may be possible that clinically relevant findings are
detected, for example heart rhythm abnormalities. Such findings will be
communicated with the subject and the general practitioner of the subject. If
subjects do not want this to happen, they will be excluded from participation.
Sterkselseweg 65
Heeze 5590AB
NL
Sterkselseweg 65
Heeze 5590AB
NL
Listed location countries
Age
Inclusion criteria
For this study we aim to include 100 healthy participants, both males and females between 18 and 65 years old. Furthermore, participants should live at a driving distance of less than approximately 70 km from Kempenhaeghe. This includes the regions Limburg-Noord, Brabant-Noord, Brabant-Zuidoost, Midden-Brabant and Gelderland-Zuid. Furthermore, participants must be able to read and speak Dutch.
Exclusion criteria
- Any diagnosed sleep disorders
o
- PSQI *6
- ISI >7
- Indication of depression or anxiety disorder meausered with the HADS (score >8)
- Pregnancy
- Participants who lack the functional capacity to provide informed consent
- Participants who suffer from any clinically relevant neurologic or psychiatric disorders or other somatic disorder, that influences sleep or is limiting the ability to adhere to the study procedures (for example schizophrenia or alcohol abuse)
- Shift-workers
- Use of any medication, except for birth control medicine
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63360.015.17 |
| Other | Registratie zal zsm plaatsvinden |
| OMON | NL-OMON28017 |