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| Name | Class |
|---|---|
| University Hospital, Grenoble | OTHER |
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The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks:
The primary objective is to verify that the PASITHEA system is able to detect apneas and hypopneas reliably.
The main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders.
Another objective of the study is to verify the safety of the PASITHEA system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinesthetic stimulation | Device | The kinesthetic actuator is placed on the skin near the ear and emits vibrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events. | During the night of the recording, the PASITHEA system and the PSG will be positioned in parallel. PSG-scored events will be matched with the output of the real-time detector: a true positive event is defined as an event detected less than 10 seconds before or within the duration of a PSG-annotated events. Apneas detected as hypopneas (and reciprocally) will be regarded as true positives. Sensitivity and positive predictive value will be calculated as per conventional definintion and the 9% confidence interval will be calculated using the Wilson score. | 1 night |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011 | All adverse events will be recorded and assessed according to ISO 14155, rev 2011 | 1 night |
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Inclusion Criteria:
Exclusion Criteria:
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Severe untreated obstructive SAS patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49000 | France | |||
| Laboratoire du sommeil et d'EFCR; Hopital Michallon |
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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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| Grenoble |
| 38043 |
| France |
| CHU Montpellier | Montpellier | France |
| CHU Rennes | Rennes | France |
| University Hospital Tours | Tours | 37 044 | France |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |