NCT01904344

Clinical Validation of New Breathing Sensors in Patients With Respiratory Insufficiency

NXT_SLEEP: the Development of a Next Generation Sleep Monitoring Platform

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Respiratory Patients

Interventions

Type	Name	Description
DEVICE	Sensor testing and validation

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-07-22
• Last updated: 2015-05-28

Locations

1 site across 1 country: Belgium