NCT02320877

Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea

Evaluation of the Overall Effectiveness Including Cardiovascular Effects of the Custom-made, Titratable Duoblock Flex SomnoDent® MAS in the Treatment of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this prospective trial 50 patients, diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI \> 15/h sleep) will be included and treated with mandibular advancement devices (MAD). These patients will undergo cardiovascular examination; echocardiography and 24h-blood pressure monitoring, on top of the normal clinical evaluation of OSA patients. These cardiovascular examinations will take place before and during MAD therapy.

Conditions

• OSA

Interventions

Type	Name	Description
DEVICE	Mandibular Advancement Device (Somnomed Flex)	The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature

Timeline

• Start date: 2014-12-01
• Primary completion: 2021-01-01
• Completion: 2021-01-01
• First posted: 2014-12-19
• Last updated: 2021-01-20

Locations

1 site across 1 country: Belgium