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

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

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 Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Device: Mandibular Advancement Device (Somnomed Flex)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mandibular Advancement Device; Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway.	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; Other Names: Somnomed Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Investigators: Principal Investigator: Olivier Vanderveken, MD, PhD, University Hospital, Antwerp

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: November 24, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Methaqualone
• Other Study ID Numbers: B300201422483