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| Name | Class |
|---|---|
| National Research Agency, France | OTHER |
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This study aims at quantifying the performance of kinesthetic stimulation to reduce the burden of obstructive sleep apneas and hypopneas.
Severe sleep apnea patients will undergo two polysomnographies (PSG), one with kinesthetic stimulation triggered on the detection of apneas and hypopneas (treated night ) and the other without kinesthetic stimulation (non-treated night ). Comparison of apnea and hypopnea indices (AHI) and of oxygen saturation between the treated and non-treated night will be taken as indicators to quantify the performance of this potential new therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment ON | Experimental | Kinesthetic stimulation administered during one night |
|
| Treatment OFF | No Intervention | NO kinesthetic stimulation administered during one night |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinesthetic stimulation | Device | Activation of mechanoreceptors by vibration bursts |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of responder to the therapy | A patient is defined as 'responder' to the therapy by comparison of the treated night to the non-treated night based on:
| Day 1 post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse device effect | Adverse Events related to the investigational device | Day 1 post-discharge |
| Effect on apneas/hypopneas duration | Therapy effect on shortening respiratory events |
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Inclusion Criteria:
Patients who meet all the following criteria at the time of enrollment may be included:
Exclusion Criteria:
Patients who meet any one of these criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Beziers | Béziers | 34500 | France | |||
| University Hospital Grenoble |
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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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| Day 1 post-discharge |
| Effect on modified apnea hypopnea index | The modified apnea hypopnea indices (AHIs) will be compared between the treated and non-treated night and defined based on the duration of the respiratory disorders | Day 1 post-discharge |
| Instantaneous heart rate measurement (bpm) during the night ON and the night OFF | Day 1 post-discharge |
| Number of arousals per night - comparison night ON and night OFF | The micro-arousal index will be calculated on the polysomnography recording. | Day 1 post-discharge |
| Effect on an objective measure of somnolence (Osler) | Osler test (optional) performed after treated night and non-treated night | Day 1 post-discharge |
| Grenoble |
| 38043 |
| 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 |