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

Université de Montréal

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Somnyx ®; Device: Narval ORM ® or SomnoDent ®

Study type: Interventional

Funder types: Other

Identifiers

NCT02112435

NH-14SRP-Somnyx (Other Identifier)

14-011-CERES-D

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Narval ORM ® or SomnoDent ®

Active Comparator group

Description:

Mandibular advancement splint (Narval ORM ® or SomnoDent ®)

Treatment:

Device: Narval ORM ® or SomnoDent ®

Somnyx ®

Experimental group

Description:

Active mandibular advancement splint (Somnyx ®)

Treatment:

Device: Somnyx ®