Clinical Validation of New Breathing Sensors in Patients With Respiratory Insufficiency

Respiratory Patients Clinical Trial

— NXT_SLEEP  

Official title:

NXT_SLEEP: the Development of a Next Generation Sleep Monitoring Platform

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904344
• Other study ID #: PML_NXT_SLEEP
• Status: Completed
• Phase: N/A
• First received: July 8, 2013
• Last updated: May 27, 2015
• Start date: June 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are hospitalized for their respiratory disease

• Written informed consent obtained

Exclusion Criteria:

• Patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially comprise the results of interpretation of the study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Patients

Intervention

Device:
• Sensor testing and validation

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	iMinds

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in breathing pattern during sleep by a movement sensor	New innovative sensors will measure breathing pattern during the night, simultaneously with the classical monitoring systems in order to validate the new sensors.	During 5 nights	No
Secondary	Change in ECG		During 5 nights	No
Secondary	Change in end tidal carbon dioxide fraction		During 5 nights	No