search
Back to results

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

Primary Purpose

OSA

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Mandibular Advancement Device (Somnomed Flex)
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mandibular Advancement Device

Arm Description

Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway.

Outcomes

Primary Outcome Measures

cardiovascular outcome - interventricular septum thickness
interventricular septum thickness
cardiovascular outcome - ventricular dilatation
ventricular dilatation
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.
cardiovascular outcome - stroke volume
stroke volume

Secondary Outcome Measures

OSA efficacy: apnea-hypopnea index
benefit in apnea-hypopnea index
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
efficacy on subjective complaints: epworth sleepiness scale
daytime sleepiness measured using epworth sleepiness scale
efficacy on subjective complaints: visual analogue scale for snoring
visual analogue scale for snoring

Full Information

First Posted
November 24, 2014
Last Updated
January 15, 2021
Sponsor
University Hospital, Antwerp
search

1. Study Identification

Unique Protocol Identification Number
NCT02320877
Brief Title
Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mandibular Advancement Device
Arm Type
Experimental
Arm Description
Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway.
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Device (Somnomed Flex)
Other Intervention Name(s)
Somnomed Flex
Intervention Description
The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature
Primary Outcome Measure Information:
Title
cardiovascular outcome - interventricular septum thickness
Description
interventricular septum thickness
Time Frame
1 year
Title
cardiovascular outcome - ventricular dilatation
Description
ventricular dilatation
Time Frame
1 year
Title
cardiovascular outcome - cardiac strain
Description
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
Title
cardiovascular outcome - stroke volume
Description
stroke volume
Time Frame
1 year
Secondary Outcome Measure Information:
Title
OSA efficacy: apnea-hypopnea index
Description
benefit in apnea-hypopnea index
Time Frame
1 year
Title
Therapy compliance
Description
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
Title
efficacy on subjective complaints: epworth sleepiness scale
Description
daytime sleepiness measured using epworth sleepiness scale
Time Frame
1 year
Title
efficacy on subjective complaints: visual analogue scale for snoring
Description
visual analogue scale for snoring
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Vanderveken, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antwerp University Hospital
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
34728052
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs