NCT01904344

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

July 8, 2013

Last Update Submit

May 27, 2015

Conditions

Respiratory Patients

Keywords

SleepSleep- related breathing disordersRespiratory pathology

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Change in ECG

    During 5 nights

  • Change in end tidal carbon dioxide fraction

    During 5 nights

Study Arms (1)

Sensor testing and validation

OTHER
Device: Sensor testing and validation

Interventions

Sensor testing and validationDEVICE
Sensor testing and validation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who are hospitalized for their respiratory disease
  • Written informed consent obtained

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Study Officials

  • Wilfried De Backer, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 22, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

BE(1)