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

Antwerp University Hospital (UZA)

Status: Completed

Conditions: OSA

Treatments: Device: Mandibular Advancement Device (Somnomed Flex)

Study type: Interventional

Funder types: Other

Identifiers

NCT02320877

B300201422483

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AHI > 15 events/hour
• No other active OSA therapy in the 3 months preceding inclusion
• Willing to participate after informed consent
• Positive advice on OAT after DISE

Exclusion criteria

• Insufficient teeth to support the device
• Periodontal problems including tooth mobility
• Active temporomandibular joint dysfunction
• Limited maximum protrusive capacity (< 6 mm)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Mandibular Advancement Device

Experimental group

Description:

Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway.

Treatment:

Device: Mandibular Advancement Device (Somnomed Flex)