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Clinical Validation of New Breathing Sensors in Patients With Respiratory Insufficiency

NXT_SLEEP: the Development of a Next Generation Sleep Monitoring Platform

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01904344
Acronym
NXT_SLEEP
Enrollment
28
Registered
2013-07-22
Start date
2013-06-30
Completion date
2014-12-31
Last updated
2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Patients

Keywords

Sleep, Sleep- related breathing disorders, Respiratory pathology

Brief 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

Interventions

DEVICESensor testing and validation

Sponsors

iMinds
CollaboratorINDUSTRY
University Hospital, Antwerp
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in breathing pattern during sleep by a movement sensorDuring 5 nightsNew innovative sensors will measure breathing pattern during the night, simultaneously with the classical monitoring systems in order to validate the new sensors.

Secondary

MeasureTime frame
Change in ECGDuring 5 nights
Change in end tidal carbon dioxide fractionDuring 5 nights

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026