Respiratory Patients Clinical Trial
Official title:
NXT_SLEEP: the Development of a Next Generation Sleep Monitoring Platform
The NXT_SLEEP study, bringing together industry partners, research groups and (home) care
providers, tackles will develop a next generation sleep-monitoring platform that consists of
less obtrusive sensors, and that delivers complete and useful information regarding the
physiological parameters relevant for sleep-related breathing disorders.
These new and innovative sensors need to be validated in a clinical setting where they will
be benchmarked with the classical sleep monitoring systems. In order to compare the novel
sensors with the classical monitoring system, the investigators use existing technologies
that capture simultaneously the acquired signals of different physiological parameters
relevant for sleep-related breathing disorders.
Sleep-related breathing disorders are recognized as major risk factors for mortality due to
their effect on the cardiovascular system. Currently, these sleeping disorders are diagnosed
using polysomnography (PSG), which is a sleep test that monitors different physiological
signals such as heart rate, respiration, ECG, muscle tone and eye movement.
Although polysomnography is an important diagnostic tool for sleep medicine, it is an
uncomfortable and costly procedure, especially when multiple nights of observation are
required. In order to reduce costs and improve patients comfort, different home monitoring
systems (using different numbers and type of sensors) have been introduced to the market,
but those focus especially on self-screening and collect general sleep information. In
addition to increasing comfort and reducing costs, the diagnostic capabilities of PSG need
to be enhanced. This can be achieved by adding novel sensors that may capture new
information and improve the measurement of vital physiological parameters during sleep
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT00640718 -
Evaluation of EverOn™ System in Medical / Surgical Ward
|
N/A |