OSANCT02320877
Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea
A study testing Mandibular Advancement Device (Somnomed Flex) in people with OSA, run by University Hospital, Antwerp at 1 site in Belgium.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA
- What is being tested?
- Mandibular Advancement Device (Somnomed Flex)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2014to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insufficient teeth to support the device
- Periodontal problems including tooth mobility
- Active temporomandibular joint dysfunction
- Limited maximum protrusive capacity (< 6 mm)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- OSA
- Being tested
- Mandibular Advancement Device (Somnomed Flex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement Device (Somnomed Flex)Device
Also called Somnomed Flex
The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature
| Study group | Role | What they receive |
|---|---|---|
| Mandibular Advancement Device | Experimental | Mandibular advancement Devices are worn intra-orally at night in order to advance the mandible and to reduce the collapsibility of the upper airway. Receives: Device: Mandibular Advancement Device (Somnomed Flex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiovascular outcome - interventricular septum thickness
interventricular septum thickness
Measured: 1 year
cardiovascular outcome - ventricular dilatation
ventricular dilatation
Measured: 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.
Measured: 1 year
cardiovascular outcome - stroke volume
stroke volume
Measured: 1 year
Secondary outcomes (4)
OSA efficacy: apnea-hypopnea index
benefit in apnea-hypopnea index
Measured: 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
Measured: 1 year
efficacy on subjective complaints: epworth sleepiness scale
daytime sleepiness measured using epworth sleepiness scale
Measured: 1 year
efficacy on subjective complaints: visual analogue scale for snoring
visual analogue scale for snoring
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2021
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ethisch.comite@uza.be, University Hospital, Antwerp
- Investigators
- Olivier Vanderveken, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320877
- Sponsor's protocol ID
- B300201422483
- Status last verified
- Jan 2021
- First submitted
- 24 Nov 2014
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 34728052
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02320877
- Acronym / sponsor ID
- B300201422483
- Conditions
- OSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mandibular Advancement Device | Experimental | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Insufficient teeth to support the device
- Periodontal problems including tooth mobility
- Active temporomandibular joint dysfunction
- Limited maximum protrusive capacity (< 6 mm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular Advancement Device (Somnomed Flex)Also: Somnomed FlexThe SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature | Device | Mandibular Advancement Device |
Primary outcome
cardiovascular outcome - interventricular septum thickness
Time frame: 1 year
interventricular septum thickness
cardiovascular outcome - ventricular dilatation
Time frame: 1 year
ventricular dilatation
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.
cardiovascular outcome - stroke volume
Time frame: 1 year
stroke volume
4 secondary outcomes
OSA efficacy: apnea-hypopnea index
Time frame: 1 year
Therapy compliance
Time frame: 1 year
efficacy on subjective complaints: epworth sleepiness scale
Time frame: 1 year
efficacy on subjective complaints: visual analogue scale for snoring
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 34728052Dieltjens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Vanderveken, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Advancement Device (Somnomed Flex) in people with OSA, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiovascular outcome - interventricular septum thickness (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.