OSA
Conditions
Brief 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.
Interventions
DEVICEMandibular Advancement Device (Somnomed Flex)
The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature
Sponsors
University Hospital, Antwerp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular outcome - stroke volume | 1 year | stroke volume |
| cardiovascular outcome - interventricular septum thickness | 1 year | interventricular septum thickness |
| cardiovascular outcome - ventricular dilatation | 1 year | ventricular dilatation |
| cardiovascular outcome - cardiac strain | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OSA efficacy: apnea-hypopnea index | 1 year | benefit in apnea-hypopnea index |
| Therapy compliance | 1 year | 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 |
| efficacy on subjective complaints: epworth sleepiness scale | 1 year | daytime sleepiness measured using epworth sleepiness scale |
| efficacy on subjective complaints: visual analogue scale for snoring | 1 year | visual analogue scale for snoring |
Countries
Belgium
Outcome results
None listed