NCT02112435

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Université de Montréal · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Somnyx ®	Active mandibular advancement splint
DEVICE	Narval ORM ® or SomnoDent ®	Mandibular advancement splint

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2014-04-14
• Last updated: 2024-03-29

Locations

3 sites across 2 countries: Canada, France