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

OSA Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320877
• Other study ID #: B300201422483
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: January 2021

Study information

• Verified date: January 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• OSA
• Sleep Apnea, Obstructive

Intervention

Device:
• Mandibular Advancement Device (Somnomed Flex)
The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular outcome - interventricular septum thickness	interventricular septum thickness	1 year
Primary	cardiovascular outcome - ventricular dilatation	ventricular dilatation	1 year
Primary	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
Primary	cardiovascular outcome - stroke volume	stroke volume	1 year
Secondary	OSA efficacy: apnea-hypopnea index	benefit in apnea-hypopnea index	1 year
Secondary	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
Secondary	efficacy on subjective complaints: epworth sleepiness scale	daytime sleepiness measured using epworth sleepiness scale	1 year
Secondary	efficacy on subjective complaints: visual analogue scale for snoring	visual analogue scale for snoring	1 year