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| Name | Class |
|---|---|
| Commissariat A L'energie Atomique | OTHER_GOV |
| AIRFAN | UNKNOWN |
| AGIR Ã Dom | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ApneaBand | Device | Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 days |
| External reproductibility of AHI measurement by the ApneaBand |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis PEPIN, Pr | CHU Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Grenoble-Alpes | La Tronche | Isère | 38700 | France |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Reproducibility between AHI from polysomnography and ApneaBand |
| 3 days |
| Internal reproductibility of AHI measurement by the ApneaBand | Reproducibility between different AHI mesures from ApneaBand | 3 days |
| ApneaBand algorith validation for AHI measurement | External validation of the ApneaBand algorithm | 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 | 3 days |
| Skin tone variability | To asses if oxygen saturation assessed by the ApneaBand could be performed in persons with dark skin tones | 3 days |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |