Obstructive Sleep Apnea (OSA)RACEMADTNCT06837285
Clinial Study of Treatment With Mandibular Advancement Device in Patients With Obstructive Sleep Apnea Across 6 General Hospitals
An observational study of Obstructive Sleep Apnea (OSA) and Mandibular Advancement Device, run by University Hospital, Antwerp at 6 sites in Belgium.
Trial summary
Study Objectives: To retrospectively study mandibular advancement treatment efficacy using apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), in a large cohort of patients, in 'real world' settings across 6 general hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA), Mandibular Advancement Device
- What is being tested?
- mandibular advancement device
- Type of treatment
- Medical device
- How many people
- 182 participants
- Where
- 6 sitesBelgium
- Study dates
- 22 Sep 2021to 24 Oct 2024
- Phase
- Observational
- 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
Study population: patients referred by sleep physicians and after ear-nos-troat-specialist examination, for mandibular advancement treatment in routine clinical settings.
Who may be able to join
- obstructive apnea-hypopnea index ≥ 15 events/h sleep
- complete clinical pathway
Who cannot join
- obstructive apnea-hypopnea index < 15 events/h sleep
- not dental fit
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
AZ Monica
Antwerp, 2000
Imelda Ziekenhuis Bonheiden
Bonheiden, Mechelen, 2820
Heilig Hartziekenhuis Lier
Lier, 2500
AZ Voorkempen
Malle, Antwerpen, 2390
AZ Sint-Maarten
Mechelen, 2800
VITAZ
Sint-Niklaas, Oost-Vlaanderen, 9100
About this study
Official title: Real-World Assessment of Clinical Evidence for Mandibular Advancement Treatment of Obstructive Sleep Apnea
Study Objectives: To retrospectively study mandibular advancement treatment efficacy using apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), in a large cohort of patients, in 'real world' settings across 6 general hospitals.
Methods: Diagnosis at 6 Belgian recognised OSA sleepcenters with type-1 polysomnography. After drug-induced sleep endoscopy by Ear-Nose-Troat-specialist, patients with positive effect of mandibular protrusion on reopening the upper airway were referred. The mandibular advancement device (MAD) was fitted in 'maximal comfortable protrusion' minus 2mm. A type-3 home polygraphy with MAD followed titration.
Read the detailed description
Methods Patients were diagnosed at conventionalized Belgian OSA sleep centers, in alphabetical order: AZ Monica (Antwerpen), AZ Sint-Maarten (Mechelen), AZ Voorkempen (Malle), Heilig Hart Ziekenhuis (Lier), Imelda Ziekenhuis (Bonheiden), and VITAZ (Sint-Niklaas), with a type 1 polysomnography. The apnea-hypopnea index (AHI; number of events/h sleep), oxygen desaturation index (ODI; number of desaturations/h sleep) and body mass index (BMI; kg/m2) were calculated.
The Ear-Nose-Troat-specialist at the OSA sleep center performed an awake examination of the upper airway, followed by a drug-induced sleep endoscopy (DISE). Patients with positive effect of mandibular protrusion on reopening of the upper airway were referred to the dental sleep professional (DSP) for dental clinical and/or radiological examination. The DSP registered the mandibular protrusive trajectory with a bite registration device (The BiteFix, Scheu-Dental, Iserlohn, Germany) and a hard bite registration paste (Futar Fast, Kettenbach, Germany), as to achieve a stable fit on both tooth arcs. Next, the 'maximal comfortable protrusion' (MCP, mm) of the mandible was determined, being the most forward mandibular protrusion still tolerated by the patient and tested during DISE.
At the time of fitting, the patients received full explanation on the MAD titration schedule and were instructed to titrate after fitting of the MAD till resolution of the snoring symptoms or upon reaching physiological limits. A 1-month follow-up was performed by telephone. Next, a type 3 home polygraphy with the MAD was organized between 3 to 5 months after treatment start, recording identical parameters as at baseline, making each patient to serve as the own control.
Inclusion In Belgium, the reimbursement criterion for MADt leaves out central apneas in the calculation of AHI and requires this 'obstructive AHI' (OAHI) to be ≥ 15 events/h. In the absence of any central event, the OAHI = AHI, whereas in the presence of central events OAHI < AHI. Patients with OAHI ≥ 15 events/h and therefore AHI ≥ 15 events/h were included on the condition that the full clinical pathway as described before was followed and that the MAD was self-reportedly used at least 4 hours per night. Further reporting is done on AHI, for reasons of comparison with other studies.
Parameters Age (years) and gender (Male/Female, M/F) were noted. Questionnaires were used at baseline and controls for the quantification of snoring using a visual analogue score on loudness (VAS-snore) with a Likert-scale from 0 (no snoring) up to 10 (partner sleeps in other room). A VAS-snore > 3/10 represents socially disturbing snoring. The Epworth sleepiness score (ESS) quantifies daytime sleepiness with ESS ≥ 11/24 representing increased propensity to fall asleep during daytime.
Mandibular advancement device The starting position of the MADt was set at MCP minus 2mm (MCP-2, mm). Digital imprints of both tooth arcs were taken (Trios, 3Shape, Copenhagen, Denmark) as well of the bite-registration in the MCP-2 position. The selected MAD (EVO, ProSomnus Sleep Technologies, Pleasanton, CA, USA) uses a Class IV resin (United States Pharmacopeia and National Formulary) which is the highest grade of material currently available. Its design is characterized by perpendicular rectangular posts to protrude the mandible. Such design could preserve mandibular advancement even during limited mouth opening while asleep. The fully digital manufacturing pathway, starting from the digital intra-oral scans up to the 3D milling, favors accuracy-of-fit on the dental arcs.
- Being tested
- mandibular advancement device
- Keywords
- obstructive sleep apnea, non invasive therapy, mandibular advancement device
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandibular advancement deviceDevice
Results of clinical trials on MADs are regularly published in the international literature but are generally very strongly controlled studies, still far away from being applied in routine daily clinical practice. The current retrospective study evaluates real-world data to determine the extent to which MAD improves both symptoms in patients with OSA. It is estimated that about 3% of newly diagnosed OSA patients are treated with MAD. In the light of new future treatment conventions, health government departments are increasingly demanding real-world data to stimulate knowledge of the relative effectiveness and value of treatments in the management of patients in routine clinical settings.
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory index "apnea-hypopnea index" (AHI)
The first primary outcome is an expected improvement in apnea-hypopnea index (AHI; number of apneas and hypopneas per hour of sleep; a higher AHI means more severe obstructive sleep apnea) upon MAD treatment (MADt). Functional objective outcome measure is the quantification of the effect of MADt on AHI. "Success" is defined as treatment AHI≤15 events/h following the Belgian threshold for reimbursement, and any decrease in baseline AHI.
Measured: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
Respiratory index "oxygen desaturation index" (ODI)
The second primary outcome is an expected improvement in respiratory parameter oxygen desaturation index (ODI; number of desaturations per hour of sleep; a higher ODI means a more severe condition) upon MAD treatment (MADt). Functional objective outcome measure is the quantification of the effect of MADt on ODI. "Success" is defined as treatment AHI≤15 events/h following the Belgian threshold for reimbursement, and any decrease in baseline AHI.
Measured: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
Obstructive sleep apnea severity
The third primary outcome is an expected improvement in OSA severity category upon MAD treatment (MADt). Categories are defined as AHI 5-14.9/hour = mild OSA; AHI 15-29.9/hour = moderate OSA; and OSA ≥30/hour = severe OSA.
Measured: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
Visual analogue score for snoring
The fourth primary outcome is an expected improvement in snoring as reported by the patient. This functional subjective outcome measure quantifies the snoring using a questionnaire with a visual analogue score on loudness of snoring (VAS-snore) with a Likert-scale from 0 (no snoring) up to 10 (partner sleeps in other room). A VAS-snore > 3/10 represents socially disturbing snoring. The higher the VAS-snore score the louder the snoring is.
Measured: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
Epworth Sleepiness Scale
The fifth primary outcome is an expected improvement in daytime sleepiness as reported by the patient. This functional subjective outcome measure quantifies the propensity to fall asleep during daytime activities, using a questionnaire with with the Epworth Sleepiness Score-scale (ESS) from 0 (no propensity to fall asleep) up to 24 (extremely high propensity to fall asleep). An EES-score ≥ 11/24 represents a pathological increased daytime sleepiness. The higher the ESS-score the more pronounce the daytime sleepiness is.
Measured: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
Titration
The sixth primary outcome is the amount of titration required at the moment when the control home-polygraphy (HPG) is recorded. The starting position of the MADt was set at the maximal comfortable protrusion (MCP) minus 2mm: first the mandibular maximal protrusive trajectory was measured in millimeters. Next, MCP was determined, being the most forward mandibular protrusion still tolerated by the patient. The actual protrusive position of the MAD at the time of the HPG minus the start position quantifies the amount of protrusion. This result cannot be interpreted in terms of a 'higher' protrusion as a 'better' protrusion since this is a patient specific characteristic, as is the range of mandibular protrusion.
Measured: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start22 Sep 2021
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Sint-Maarten, AZ Voorkempen, AZ Monica Campus Antwerpen, Imelda Hospital, Bonheiden, Vitaz, Regionaal Ziekenhuis Heilig Hart Tienen
- Responsible party
- Principal investigator, Marc Braem, University Hospital, Antwerp
- Investigators
- Marc J BRAEM, DDS, PhD, Principal investigator, UZA Afd. Tandheelkunde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837285
- Sponsor's protocol ID
- EVO_AZ-Sites_2025
- Acronym
- RACEMADT
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Assessment of Clinical Evidence for Mandibular Advancement Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06837285
- Acronym / sponsor ID
- RACEMADT / EVO_AZ-Sites_2025
- Keywords
- obstructive sleep apnea, non invasive therapy, mandibular advancement device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- AZ Sint-Maarten, AZ Voorkempen, AZ Monica Campus Antwerpen, Imelda Hospital, Bonheiden, Vitaz, Regionaal Ziekenhuis Heilig Hart Tienen
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 20 Feb 2025 (actual)
- 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.
Study Objectives: To retrospectively study mandibular advancement treatment efficacy using apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), in a large cohort of patients, in 'real world' settings across 6 general hospitals.
Methods: Diagnosis at 6 Belgian recognised OSA sleepcenters with type-1 polysomnography. After drug-induced sleep endoscopy by Ear-Nose-Troat-specialist, patients with positive effect of mandibular protrusion on reopening the upper airway were referred. The mandibular advancement device (MAD) was fitted in 'maximal comfortable protrusion' minus 2mm. A type-3 home polygraphy with MAD followed titration.
Detailed description
Methods Patients were diagnosed at conventionalized Belgian OSA sleep centers, in alphabetical order: AZ Monica (Antwerpen), AZ Sint-Maarten (Mechelen), AZ Voorkempen (Malle), Heilig Hart Ziekenhuis (Lier), Imelda Ziekenhuis (Bonheiden), and VITAZ (Sint-Niklaas), with a type 1 polysomnography. The apnea-hypopnea index (AHI; number of events/h sleep), oxygen desaturation index (ODI; number of desaturations/h sleep) and body mass index (BMI; kg/m2) were calculated.
The Ear-Nose-Troat-specialist at the OSA sleep center performed an awake examination of the upper airway, followed by a drug-induced sleep endoscopy (DISE). Patients with positive effect of mandibular protrusion on reopening of the upper airway were referred to the dental sleep professional (DSP) for dental clinical and/or radiological examination. The DSP registered the mandibular protrusive trajectory with a bite registration device (The BiteFix, Scheu-Dental, Iserlohn, Germany) and a hard bite registration paste (Futar Fast, Kettenbach, Germany), as to achieve a stable fit on both tooth arcs. Next, the 'maximal comfortable protrusion' (MCP, mm) of the mandible was determined, being the most forward mandibular protrusion still tolerated by the patient and tested during DISE.
At the time of fitting, the patients received full explanation on the MAD titration schedule and were instructed to titrate after fitting of the MAD till resolution of the snoring symptoms or upon reaching physiological limits. A 1-month follow-up was performed by telephone. Next, a type 3 home polygraphy with the MAD was organized between 3 to 5 months after treatment start, recording identical parameters as at baseline, making each patient to serve as the own control.
Inclusion In Belgium, the reimbursement criterion for MADt leaves out central apneas in the calculation of AHI and requires this 'obstructive AHI' (OAHI) to be ≥ 15 events/h. In the absence of any central event, the OAHI = AHI, whereas in the presence of central events OAHI < AHI. Patients with OAHI ≥ 15 events/h and therefore AHI ≥ 15 events/h were included on the condition that the full clinical pathway as described before was followed and that the MAD was self-reportedly used at least 4 hours per night. Further reporting is done on AHI, for reasons of comparison with other studies.
Parameters Age (years) and gender (Male/Female, M/F) were noted. Questionnaires were used at baseline and controls for the quantification of snoring using a visual analogue score on loudness (VAS-snore) with a Likert-scale from 0 (no snoring) up to 10 (partner sleeps in other room). A VAS-snore > 3/10 represents socially disturbing snoring. The Epworth sleepiness score (ESS) quantifies daytime sleepiness with ESS ≥ 11/24 representing increased propensity to fall asleep during daytime.
Mandibular advancement device The starting position of the MADt was set at MCP minus 2mm (MCP-2, mm). Digital imprints of both tooth arcs were taken (Trios, 3Shape, Copenhagen, Denmark) as well of the bite-registration in the MCP-2 position. The selected MAD (EVO, ProSomnus Sleep Technologies, Pleasanton, CA, USA) uses a Class IV resin (United States Pharmacopeia and National Formulary) which is the highest grade of material currently available. Its design is characterized by perpendicular rectangular posts to protrude the mandible. Such design could preserve mandibular advancement even during limited mouth opening while asleep. The fully digital manufacturing pathway, starting from the digital intra-oral scans up to the 3D milling, favors accuracy-of-fit on the dental arcs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred by sleep physicians and after ear-nos-troat-specialist examination, for mandibular advancement treatment in routine clinical settings.
Key inclusion criteria (2 listed)
- obstructive apnea-hypopnea index ≥ 15 events/h sleep
- complete clinical pathway
Key exclusion criteria (2 listed)
- obstructive apnea-hypopnea index < 15 events/h sleep
- not dental fit
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 deviceResults of clinical trials on MADs are regularly published in the international literature but are generally very strongly controlled studies, still far away from being applied in routine daily clinical practice. The current retrospective study evaluates real-world data to determine the extent to which MAD improves both symptoms in patients with OSA. It is estimated that about 3% of newly diagnosed OSA patients are treated with MAD. In the light of new future treatment conventions, health government departments are increasingly demanding real-world data to stimulate knowledge of the relative effectiveness and value of treatments in the management of patients in routine clinical settings. | Device | – |
Primary outcome
Respiratory index "apnea-hypopnea index" (AHI)
Time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
The first primary outcome is an expected improvement in apnea-hypopnea index (AHI; number of apneas and hypopneas per hour of sleep; a higher AHI means more severe obstructive sleep apnea) upon MAD treatment (MADt). Functional objective outcome measure is the quantification of the effect of MADt on AHI. "Success" is defined as treatment AHI≤15 events/h following the Belgian threshold for reimbursement, and any decrease in baseline AHI.
Respiratory index "oxygen desaturation index" (ODI)
Time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
The second primary outcome is an expected improvement in respiratory parameter oxygen desaturation index (ODI; number of desaturations per hour of sleep; a higher ODI means a more severe condition) upon MAD treatment (MADt). Functional objective outcome measure is the quantification of the effect of MADt on ODI. "Success" is defined as treatment AHI≤15 events/h following the Belgian threshold for reimbursement, and any decrease in baseline AHI.
Obstructive sleep apnea severity
Time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
The third primary outcome is an expected improvement in OSA severity category upon MAD treatment (MADt). Categories are defined as AHI 5-14.9/hour = mild OSA; AHI 15-29.9/hour = moderate OSA; and OSA ≥30/hour = severe OSA.
Visual analogue score for snoring
Time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
The fourth primary outcome is an expected improvement in snoring as reported by the patient. This functional subjective outcome measure quantifies the snoring using a questionnaire with a visual analogue score on loudness of snoring (VAS-snore) with a Likert-scale from 0 (no snoring) up to 10 (partner sleeps in other room). A VAS-snore > 3/10 represents socially disturbing snoring. The higher the VAS-snore score the louder the snoring is.
Epworth Sleepiness Scale
Time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
The fifth primary outcome is an expected improvement in daytime sleepiness as reported by the patient. This functional subjective outcome measure quantifies the propensity to fall asleep during daytime activities, using a questionnaire with with the Epworth Sleepiness Score-scale (ESS) from 0 (no propensity to fall asleep) up to 24 (extremely high propensity to fall asleep). An EES-score ≥ 11/24 represents a pathological increased daytime sleepiness. The higher the ESS-score the more pronounce the daytime sleepiness is.
Titration
Time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD
The sixth primary outcome is the amount of titration required at the moment when the control home-polygraphy (HPG) is recorded. The starting position of the MADt was set at the maximal comfortable protrusion (MCP) minus 2mm: first the mandibular maximal protrusive trajectory was measured in millimeters. Next, MCP was determined, being the most forward mandibular protrusion still tolerated by the patient. The actual protrusive position of the MAD at the time of the HPG minus the start position quantifies the amount of protrusion. This result cannot be interpreted in terms of a 'higher' protrusion as a 'better' protrusion since this is a patient specific characteristic, as is the range of mandibular protrusion.
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Marc J BRAEM, DDS, PhD principal investigator
UZA Afd. Tandheelkunde
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA) and Mandibular Advancement Device, run by University Hospital, Antwerp at 6 sites 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 2 inclusion and 2 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Respiratory index "apnea-hypopnea index" (AHI) (time frame: From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2025.