An observational study in Obstructive Sleep Apnea, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-04.
Sponsored by University Hospital, Grenoble · Observational
This prospective study aims to evaluate a new medical screening method to detect and discriminate sleep apnea-hypopnea events. A new device called ApneaBand will be tested to propose a new screening method facilitating the diagnosis and monitoring of the sleep apnea syndrom, still underdiagnosed. This device will be tested in comparison with polysomnography (PSG), the gold standard reference method of sleep apnea diagnosis.
The objective of this study is to dertermine the performance of the ApneaBand, a new non-intrusive and portable device, in detecting sleep apnea, in comparison with PSG.
40 apneic and non apneic subjects will wear the ApneaBand recording the different sleep stages and the occurency of apnea-hypopnea sleep events through four sensors including oximetry (oxygen saturation), photoplethysmography (pulse wave), electrodermal activity and tri-axial accelerometer (movements).
Inclusion visit will be proceeded at the University Hospital Grenoble-Alpes ; polysomnography and mesures by the ApneaBand will be proceeded at the patient's home by IC@dom. Patients will be equiped with PSG + ApneaBand during the first night and with ApneaBand only the second night.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 45 is below the median of 106 across 386 observational studies indexed under Apnea.
Browse Apnea studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer)
Performance of the ApneaBand to detect sleep apnea
Performance of the ApneaBand device in detecting moderate to severe sleep apnea (defined by an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour), in comparison with PSG
Time frame: 3 days
Performance of the ApneaBand to mesure the apnea severity
Performance of the ApneaBand device in detecting sleep apnea according to its severity (2 pre-specified thresholds of AHI: \> 5 and ≥ 30), in comparison with PSG
Time frame: 3 days
External reproductibility of AHI measurement by the ApneaBand
Reproducibility between AHI from polysomnography and ApneaBand
Time frame: 3 days
Internal reproductibility of AHI measurement by the ApneaBand
Reproducibility between different AHI mesures from ApneaBand
Time frame: 3 days
ApneaBand algorith validation for AHI measurement
External validation of the ApneaBand algorithm
Time frame: 3 days
Sleep stage detection by ApneaBand
To assess if electrodermal activity assessed by the ApneaBand during sleep is able to differerenciate the different sleep stages
Time frame: 3 days
Skin tone variability
To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones
Time frame: 3 days
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble