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To evaluate the efficacy (non-inferiority) in terms of response between patients using custom fitted mandibular advancement devices ONIRIS® and patient using laboratory custom made devices TALI, after 2 months of use. Sleeping tests were performed.
Open, non-inferiority, controlled and rndomised clinical trial. Six months of inclusion. Each included patient will be followed during 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mandibular advancement devices ONIRIS® | Experimental | The patients will use the mandibular advancement devices ONIRIS® |
|
| laboratory devices TALI | Active Comparator | The patients will use the laboratory devices TALI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONIRIS® | Device | sleeping test |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacity (non-inferiority) in terms of response between patients using mandibular advancement devices ONIRIS® and patient using devices produced in a laboratoryTALI after 2 months of use. | The response to the treatment is defined as:
| 2 monthes of use |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of AHI, AI and HI | AHI per hour of sleep with the same modalities as the one used for diagnosis (realised by ambulatory PG or PSG) | at M2 and at M12 |
| Percentage of patients responder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| RAYMOND Nathalie, MD | Hôpital Bel Air | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Bel-Air | Bordeaux | France | ||||
| Polyclinique Saint Privat |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31053619 | Derived | Pepin JL, Raymond N, Lacaze O, Aisenberg N, Forcioli J, Bonte E, Bourdin A, Launois S, Tamisier R, Molinari N. Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial. Thorax. 2019 Jul;74(7):667-674. doi: 10.1136/thoraxjnl-2018-212726. Epub 2019 May 3. |
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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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| TALI |
| Device |
sleeping test |
|
Percentage of patients responder at the last control exam
| at M2 and M12 |
| Evolution during the study of the principal criteria concerning the sleep | Snoring measured by VAS, Epworth Sleepness Scale measuring daytime sleepness, Pichot Questionnaire measuring fatigue and depression | at baseline, M2, M6 and M12 |
| Evolution of the quality of life | Quality of life evaluated by SF12 at each visit | at baseline, M2, M6 and M12 |
| Evolution of the compliance | Percantage of compliance (excellent > 85%, good > 50%) | at M2, M6 and M12 |
| Evolution of tolerance | Nature, frequency and intensity of AE at each visit | at M2, M6 and M12 |
| AE and SAE occuring during the study | Description and comparison at each group of AE and SAE | at M2, M6 and M12 |
| Evolution of arterial hypertension | Arterial hypertension evaluated at each visit | at baseline, M2, M6 and M12 |
| Boujan-sur-Libron |
| France |
| CHU de Grenoble | La Tronche | France |
| Hôpital André Mignot | Le Chesnay | 78157 | France |
| Medical Practice | Les Pavillons-sous-Bois | 93320 | France |
| Medical Practice | Maisons-Alfort | France |
| CHU Montpellier | Montpellier | France |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | France |
| Medical Practice | Perpignan | France |
| Centre Cardiologique du Nord | Saint-Denis | France |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |