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This is a randomized controlled study evaluating the impact of 2 months of oral appliance therapy on endothelial function in patients with severe obstructive sleep apnea syndrome intolerant to continuous positive airway pressure (CPAP) therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMO | Experimental | Adjustable mandibular repositioning appliance |
|
| placebo | Placebo Comparator | placebo device in upper jaw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMO | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline to 2-months in reactive hyperemia index (RHI), a validated measurement of endothelial function. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline to 2-months in markers of OSA severity | 2 months | |
| change from baseline to 2-months in blood pressure | 2 months | |
| change from baseline to 2-months in symptoms of OSA |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Grenoble | Grenoble | 38100 | France | |||
| CH Le Mans |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30366971 | Derived | Recoquillon S, Pepin JL, Vielle B, Andriantsitohaina R, Bironneau V, Chouet-Girard F, Fleury B, Goupil F, Launois S, Martinez MC, Meslier N, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Gagnadoux F. Effect of mandibular advancement therapy on inflammatory and metabolic biomarkers in patients with severe obstructive sleep apnoea: a randomised controlled trial. Thorax. 2019 May;74(5):496-499. doi: 10.1136/thoraxjnl-2018-212609. Epub 2018 Oct 26. | |
| 28128967 |
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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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| 2 months |
| evaluate treatment compliance objectively measured by an embedded micro sensor | 15 weeks |
| Le Mans |
| 72100 |
| France |
| Hopital Saint Antoine | Paris | 75012 | France |
| CHU Poitiers | Poitiers | 86000 | France |
| Derived |
| Gagnadoux F, Pepin JL, Vielle B, Bironneau V, Chouet-Girard F, Launois S, Meslier N, Meurice JC, Nguyen XL, Paris A, Priou P, Tamisier R, Trzepizur W, Goupil F, Fleury B. Impact of Mandibular Advancement Therapy on Endothelial Function in Severe Obstructive Sleep Apnea. Am J Respir Crit Care Med. 2017 May 1;195(9):1244-1252. doi: 10.1164/rccm.201609-1817OC. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |