Clinical Validation of New Breathing Sensors in Patients With Respiratory Insufficiency (NXT_SLEEP)
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|ClinicalTrials.gov Identifier: NCT01904344|
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : May 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Patients||Device: Sensor testing and validation||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NXT_SLEEP: the Development of a Next Generation Sleep Monitoring Platform|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
|Sensor testing and validation||
Device: Sensor testing and validation
- Change in breathing pattern during sleep by a movement sensor [ Time Frame: During 5 nights ]New innovative sensors will measure breathing pattern during the night, simultaneously with the classical monitoring systems in order to validate the new sensors.
- Change in ECG [ Time Frame: During 5 nights ]
- Change in end tidal carbon dioxide fraction [ Time Frame: During 5 nights ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904344
|University Hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||Wilfried De Backer, MD, PhD||University Hospital, Antwerp|