Comparative Efficacy Study of Titratable Versus Active Mandibular Advancement Splint in Sleep Apnea

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study of Efficacy of Titratable Mandibular Advancement Splint Versus Active Mandibular Advancement Splint to Treat Patients With Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Somnyx ®
* Device: Narval ORM ® or SomnoDent ®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 65 years severe OSA confirmed by polysomnography (PSG) is: 30> AHI> 15 with severe daytime sleepiness - Epworth ≥ 10 or AHI> 30 patient in failure or refusal of CPAP treatment agree to participate and sign the consent form research speak and understand French without external assistance be in good health (no neurological or psychiatric syndrome). have a valid Social Security card (in France and Portugal only) Exclusion Criteria: contra-indicated dental/periodontal states for mandibular advancement splints, such as: 1) significant edentulism (less than 3 healthy teeth / quadrant), 2) generalized periodontitis or severe parodonthopathies, 3) severe disorders of the temporomandibular joint (TMJ), 4) less than 5 mm of maximal mandibular protrusion dental restorations in progress or planned in the next 6 months psychiatric and neuromuscular disorders untreated cardiovascular diseases and history of stroke or myocardial infarction severe or morbid obesity (body mass index> 35)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Narval ORM ® or SomnoDent ®<br>Mandibular advancement splint (Narval ORM ® or SomnoDent ®) | Device: Narval ORM ® or SomnoDent ®<br>* Mandibular advancement splint<br>* Other names: Mandibular repositioning splint;|
| Experimental: Somnyx ®<br>Active mandibular advancement splint (Somnyx ®) | Device: Somnyx ®<br>* Active mandibular advancement splint<br>* Other names: Oral appliance;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, mandibular advancement splint, active mandibular advancement splint, oral appliance