Clinical trial NCT01904344: Clinical Validation of New Breathing Sensors in Patients With Respiratory Insufficiency
Official title: NXT_SLEEP: the Development of a Next Generation Sleep Monitoring Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Patients
Keywords: Sleep
Sleep- related breathing disorders
Respiratory pathology
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: iMinds
First posted: 2013-07-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in breathing pattern during sleep by a movement sensor
timeFrame: During 5 nights
Secondary outcomes:
measure: Change in ECG
timeFrame: During 5 nights
measure: Change in end tidal carbon dioxide fraction
timeFrame: During 5 nights
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: