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

Not Applicable

Completed

• Conditions: OSA
• Interventions: Device: Mandibular Advancement Device (Somnomed Flex)

• Registration Number: NCT02320877
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-24
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-15
• Study First Posted: 2014-12-19
• Status Verified: 2021-01
• Primary Completion: 2021-01
• Study Completion: 2021-01
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mandibular Advancement Device	Mandibular Advancement Device (Somnomed Flex)	Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway.

Primary Outcome Measures

Name	Time	Method
cardiovascular outcome - interventricular septum thickness	1 year	interventricular septum thickness
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.
cardiovascular outcome - ventricular dilatation	1 year	ventricular dilatation
cardiovascular outcome - stroke volume	1 year	stroke volume

Secondary Outcome Measures

Name	Time	Method
efficacy on subjective complaints: visual analogue scale for snoring	1 year	visual analogue scale for snoring
efficacy on subjective complaints: epworth sleepiness scale	1 year	daytime sleepiness measured using epworth sleepiness scale
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

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium