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| ID | Type | Description | Link |
|---|---|---|---|
| NH-14SRP-Somnyx | Other Identifier | Faculté de medecine dentaire, Université de Montreal |
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| Name | Class |
|---|---|
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
| University Hospital, Montpellier | OTHER |
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Sleep apnea is a common disorder that occurs in 3-10 % of the adult population. This disorder disrupts the architecture and quality of sleep. Continuous positive airway pressure (CPAP) therapy is the standard treatment, but in some cases, it can not be used (patient refusal or intolerance). In these cases, treatment with mandibular advancement devices can bring an improvement in symptoms. Therefore, this study aims to compare the effectiveness of titratable versus active mandibular advancement splints in standard care environment. This will be based on the global response, which includes the apnea-hypopnea index and compliance in severe apnea patients who refused or where intolerant to CPAP. Following their severe apnea diagnosis and the assessment on the feasibility of placing a mandibular advancement device, follow-up visits will be scheduled after 3 months of treatment involving clinical monitoring by a physician and a dentist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narval ORM ® or SomnoDent ® | Active Comparator | Mandibular advancement splint (Narval ORM ® or SomnoDent ®) |
|
| Somnyx ® | Experimental | Active mandibular advancement splint (Somnyx ®) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somnyx ® | Device | Active mandibular advancement splint |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate (ORR) = rate of complete response (TRc) + partial response rate (PRR) =% of patients with AHI <15 or ≥ 50% reduction in AHI and compliance ≥ 5 nights / week and 5 hours / night | following 3 months of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Complete Response | Rate of Complete Response (TRc) =% Patients with AHI <15 and AHI ≥ 50% reduction and compliance ≥ 5 nights / week and 5 hours / night) | following 3 months of treatment |
| Partial response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nelly Huynh, PhD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Université de Montréal | Montreal | Quebec | H3C3J7 | Canada | ||
| Université Montpellier |
| 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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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Narval ORM ® or SomnoDent ® | Device | Mandibular advancement splint |
|
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Partial response rate =% of patients with reduction AHI ≥ 50% with AHI> 15 or AHI <15 with reduction <50% and adherence ≥ 5 nights / week and 5 hours / night) at 3 months of treatment.
| Following 3 months of treatment |
| Subjective compliance | Subjective compliance | Following 3 months of treatment |
| Sleep quality | sleep efficiency, total sleep time | Following 3 months of treatment |
| Desaturation | desaturation index, time spent below 90% | Following 3 months of treatment |
| Subjective sleep | Pittsburgh questionnaire | Following 3 months of treatment |
| Quality of life | Functional outcomes sleep questionnaire (FOSQ) | Following 3 months of treatment |
| Fatigue | Chalder fatigue questionnaire | Following 3 months of treatment |
| Subjective daytime sleepiness | Epworth sleepiness score | Following 3 months of treatment |
| Side effects | side effects and interactions with the dental evaluations | Following 3 months of treatment |
| Montpellier |
| France |
| Groupe Hospitalier Pitie-Salpetriere | Paris | France |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |