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

N/ACompletedNCT02320877

University Hospital, Antwerp100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

OSA

Interventions

Mandibular Advancement Device (Somnomed Flex)DEVICE

The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Antwerp University Hospital

Edegem, Antwerp, Belgium

Outcomes

Primary Outcomes

cardiovascular outcome - interventricular septum thickness

interventricular septum thickness

Time frame: 1 year

cardiovascular outcome - ventricular dilatation

ventricular dilatation

Time frame: 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.

Time frame: 1 year

cardiovascular outcome - stroke volume

stroke volume

Time frame: 1 year

Secondary Outcomes

OSA efficacy: apnea-hypopnea index

benefit in apnea-hypopnea index

Time frame: 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

Time frame: 1 year

efficacy on subjective complaints: epworth sleepiness scale

Data from ClinicalTrials.gov

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