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

Study Overview
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Brief Summary
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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.

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

Conditions
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OSA

Intervention / Treatment
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* Device: Mandibular Advancement Device (Somnomed Flex)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mandibular Advancement Device<br>Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway. | Device: Mandibular Advancement Device (Somnomed Flex)<br>* The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature<br>* Other names: Somnomed Flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular outcome - interventricular septum thickness | interventricular septum thickness | 1 year | 
| cardiovascular outcome - ventricular dilatation | ventricular dilatation | 1 year | 
| cardiovascular outcome - cardiac strain | cardiac strain. This will be measured on speckle tracking echocardiopgraphy (STE). STE is an echocardiographic imaging technique that analyzes the motion of heart tissue by using ultrasound waves to generate interference patterns and natural acoustic reflections. These reflections, also described as ''speckles'', are tracked consecutively frame to frame and ultimately resolved into angle-independent two-dimensional and three-dimensional strain-based sequences (3D). These sequences provide both quantitative and qualitative information regarding heart tissue deformation and motion. | 1 year | 
| cardiovascular outcome - stroke volume | stroke volume | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSA efficacy: apnea-hypopnea index | benefit in apnea-hypopnea index | 1 year | 
| Therapy compliance | Therapy compliance will be objectively monitored12 using 2 microsensors (Dentitrac®, Braebon Medical Corporation, Kanata, Ontario, Canada; TheraMon, IFT Handels- und Entwicklungsgesellschaft GmbH, Handelsagentur Gschladt, Hargelsberg, Austria) embedded in the OAm as well as by self-reporting | 1 year | 
| efficacy on subjective complaints: epworth sleepiness scale | daytime sleepiness measured using epworth sleepiness scale | 1 year | 
| efficacy on subjective complaints: visual analogue scale for snoring | visual analogue scale for snoring | 1 year |