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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mandibular Advancement Device | Experimental | Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mandibular Advancement Device (Somnomed Flex) | Device | The SomnoDent Flexâ„¢ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Vanderveken, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Edegem | Antwerp | 2650 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34728052 | Derived | Dieltjens M, Vanderveken OM, Shivalkar B, Van Haesendonck G, Kastoer C, Heidbuchel H, Braem MJ, Van De Heyning CM. Mandibular advancement device treatment and reverse left ventricular hypertrophic remodeling in patients with obstructive sleep apnea. J Clin Sleep Med. 2022 Mar 1;18(3):903-909. doi: 10.5664/jcsm.9766. |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| 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 |