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Completed

NCT Number: NCT02320877

Evaluation of the Cardiovascular Effects of the 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.

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Key information

Conditions

OSA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Other names: Somnomed Flex

Primary outcomes

  1. cardiovascular outcome - interventricular septum thickness

    Time frame: 1 year

    interventricular septum thickness

  2. cardiovascular outcome - ventricular dilatation

    Time frame: 1 year

    ventricular dilatation

  3. cardiovascular outcome - cardiac strain

    Time frame: 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.

  4. cardiovascular outcome - stroke volume

    Time frame: 1 year

    stroke volume

Secondary outcomes

  1. OSA efficacy: apnea-hypopnea index

    Time frame: 1 year

    benefit in apnea-hypopnea index

  2. Therapy compliance

    Time frame: 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

  3. efficacy on subjective complaints: epworth sleepiness scale

    Time frame: 1 year

    daytime sleepiness measured using epworth sleepiness scale

  4. efficacy on subjective complaints: visual analogue scale for snoring

    Time frame: 1 year

    visual analogue scale for snoring

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2014
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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