Evaluation of the Cardiovascular Effects of the MAS in the Treatment of Obstructive Sleep Apnea
NCT ID: NCT02320877
Last Updated: 2021-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
100 participants
INTERVENTIONAL
2014-12-31
2021-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinial Study of Treatment With Mandibular Advancement Device in Patients With Obstructive Sleep Apnea Across 6 General Hospitals
NCT06837285
First Line Obstructive Sleep Apnea Treatment Study
NCT05393531
Sleep Positional Trainer for Positional Sleep Apnea After Mandibular Advancement Device (MAD) Therapy
NCT01535521
The Effect of Mandibular Advancement Devices on Markers of Cardiovascular Health in Obstructive Sleep Apnea Patients
NCT05387122
Reducing Obstructive Sleep Apnea After Hypoglossal Nerve Stimulation Through Mandibular Advancement
NCT07132307
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Periodontal problems including tooth mobility
* Active temporomandibular joint dysfunction
* Limited maximum protrusive capacity (\< 6 mm)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Antwerp
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olivier Vanderveken, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Antwerp
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Antwerp University Hospital
Edegem, Antwerp, Belgium
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B300201422483
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.