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Clinical Validation of New Breathing Sensors in Patients With Respiratory Insufficiency (NXT_SLEEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01904344
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : May 28, 2015
Information provided by (Responsible Party):
Wilfried De Backer, University Hospital, Antwerp

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.

Condition or disease Intervention/treatment Phase
Respiratory Patients Device: Sensor testing and validation Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Sensor testing and validation Device: Sensor testing and validation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in ECG [ Time Frame: During 5 nights ]
  2. Change in end tidal carbon dioxide fraction [ Time Frame: During 5 nights ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01904344

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University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
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Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp
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Responsible Party: Wilfried De Backer, MD PhD, University Hospital, Antwerp Identifier: NCT01904344    
Other Study ID Numbers: PML_NXT_SLEEP
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015
Keywords provided by Wilfried De Backer, University Hospital, Antwerp:
Sleep- related breathing disorders
Respiratory pathology