Obstructive Sleep ApneaSIMT-OSANCT06612008
Superimposition of Intra-oral Scans in MAD Therapy for OSA
An observational study of Obstructive Sleep Apnea, run by Amsterdam UMC, location VUmc.
Trial summary
Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients. Goals: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Mandibular Advancement Device
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The participants of the research will be recruited from the Department of Oral and Maxillofacial Surgery at 'Isala Hospital Zwolle' and from the orthodontic practice 'Orthodontisten Heemstede', both located in the Netherlands.
Who may be able to join
- Adults ≥ 18 years of age
- Patients with a diagnosis of OSA
- Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour
- Patients initially treated with MAD
Who cannot join
- Patients under 18 years of age
- Patients without a diagnosis of mild to moderate OSA
- Patients undergoing other treatments for OSA
- Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)
- Patients diagnosed with central sleep apnea
- Patients undergoing orthodontic treatment (e.g. braces)
Show all 12Show fewer
- Pregnant patients
- Patients with craniofacial anomalies or syndromes (e.g., Treacher-Collins, Down, Pierre-Robin, Marfan),
- Patients undergoing cancer treatment with chemotherapy or radiation
- Patients with a history of maxillofacial surgery
- Patients with select dental conditions like severe periodontal disease, temporomandibular joint disease, insufficient dentition to support appliance retention in the mouth
- Patients who use bone resorption inhibitors (such as bisphosphonates, calcitonin, SERMs) or the prolonged use, ≥ 6 months of corticosteroids
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients.
Goals:
Read more
- To track dental and jaw changes in OSA patients using 3D scans.
- To assess the impact of MAD on quality of life and cognitive function.
Study Details:
The aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging.
Outcome:
The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.
Read the detailed description
Rationale: Obstructive Sleep Apnea (OSA) significantly reduces quality of life and increases the risk of severe health issue. While Mandibular Advancement Devices (MAD) are effective in managing OSA symptoms, they often introduce undesirable dental and skeletal changes, which can have a negative impact on patient satisfaction. Recognizing this issue, this study hypothesizes that using an innovative 3D superimposition technique to track these changes will allow to compare two different titration protocols more precisely and determine the optimal approach for various patient groups. By identifying the most effective titration protocol, the aim is to enhance treatment adherence and treatment success, addressing a critical gap in existing literature and significantly improving patient outcomes in OSA treatment.
Objective:
- Investigate dental and skeletal changes in OSA patients undergoing MAD treatment using an innovative 3D superimposition technique.
- Assess the impact of MAD treatment on quality of life (QoL) and cognitive function.
Study design: A prospective multicentre observational cohort study will be conducted, involving four screening points: at the study's onset and during the first, second, and third annual follow-up assessments. This investigation will involve two patient cohorts undergoing different titration approaches: orthodontic titration and another commonly used titration protocol.
Study population: The study will include adults with mild to moderate OSA who will undergo MAD treatment.
Intervention: Participants will be fitted with a MAD as part of their routine clinical care. The intervention involves the collection of baseline intra-oral scans (IOS), lateral cephalograms (LCR), orthopantomograms (OPT), and a collection of orthodontic parameters. These assessments will be repeated at each follow-up appointment.
Main study parameters/endpoints:
- Dental and skeletal changes tracked over time using intra-oral scans (IOS), lateral cephalograms (LCR), orthopantomograms (OPT), and complete orthodontic evaluations.
- Changes in quality of life (QoL) and cognitive function assessed through validated questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will experience the routine procedure of MAD fitting and imaging assessments. The study's positive outcomes encompass advancing the knowledge of the enduring impacts of MAD treatment on oral health. Participants will not incur any additional risks by engaging in this research, as it solely involves additional routine diagnostic procedures. The study is group-related, focusing on OSA patients undergoing MAD therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Mandibular Advancement Device
- Keywords
- Obstructive Sleep Apnea, Obstructive Sleep Apnea Syndrome, Oral Appliance 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
MADs are custom-fitted oral appliances designed to reposition the mandible (lower jaw) forward during sleep, which helps to keep the airway open by preventing upper airway collapse.
| Study group | Role | What they receive |
|---|---|---|
| Stepwise titration | Patients will receive a MAD with an individualized stepwise titration protocol. Initially, the device is set at 60% advancement of the maximum protrusion. Over the first 3 months, the advancement is adjusted incrementally (to 75% or 90%) based on subjective improvement in OSA symptoms and side effects. If side effects occur, the advancement is decreased. Receives: Device: Mandibular Advancement Device | |
| Personalized titration | Patients will receive a MAD set to baseline settings. Instead of following a standard titration process, personalized titration will use both objective data and subjective patient feedback to determine the optimal advancement. This approach takes into account individual factors such as the patient's oral anatomy, sleep study results, and specific symptoms. The goal is to achieve a personalized, optimal setting that maximizes symptom improvement and comfort. Receives: Device: Mandibular Advancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental occlusal measurements
- Overbite (mm): the vertical overlap of the upper and lower teeth.
- Overjet (mm): the horizontal overlap of the upper and lower teeth.
- Maximal protrusion (mm): the most protrusive position of the mandible, independent of tooth contact.
- Maximal retrusion (mm): the most retrusive position of the mandible, independent of tooth contact.
- Protrusive range (mm): the distance between the most protrusive and most retrusive position of the mandible.
- Maximal mouth opening (mm): the maximum distance between the upper and lower incisors when the mouth is fully opened.
Measured: Baseline; Year 1; Year 2; Year 3
Molar and canine relationships
- Molar relationships (in premolar width equivalents): the relative position of the upper and lower molars.
- Canine relationships (in premolar width equivalents): the relative position of the upper and lower canines.
Measured: Baseline; Year 1; Year 2; Year 3
History of orthodontic treatment
- Previous orthodontic treatment (braces/ premolar extractions)
Measured: Baseline; Year 1; Year 2; Year 3
Secondary outcomes (3)
Cephalometric dentofacial measurements
- Dentofacial profile: Pro- and inclination (degrees)
- Sagittal facial projection: SNA (degrees), SNB (degrees), and ANB (degrees)
Measured: Baseline; Year 1; Year 2; Year 3
Cephalometric facial and mandibular measurements
- Facial height and divergence: Ar-Go⌃Me (mm), S-N⌃Ar (mm), Na-Me (mm), MP⌃S-Na (mm), and S-Go (mm)
- Mandibular dimensions: Go-Gn (mm) and Ar-Go (mm)
- Mandibular plane and hyoid point: MP-Hy (mm)
- Hyoid point and posterior pharyngeal wall: Hy-PAS (mm)
Measured: Baseline; Year 1; Year 2; Year 3
Cephalometric ratios and divergence
- Facial height and divergence: Ar-Go/N-Me (%)
Measured: Baseline; Year 1; Year 2; Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study startJul 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJul 2029 (estimated)
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 Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Jan de lange, Amsterdam UMC, location VUmc
- Investigators
- J. de Lange, Prof. Dr., Principal investigator, Amsterdam University Medical CenterJ.P.T.F. Ho, Dr., Principal investigator, Amsterdam University Medical CenterN.C.W. van der Kaaij, Dr., Principal investigator, Amsterdam University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612008
- Sponsor's protocol ID
- 202401
- Acronym
- SIMT-OSA
- Status last verified
- Jul 2025
- First submitted
- 9 Sep 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Ruiter MHT, Aarab G, de Vries N, Lobbezoo F, de Lange J. A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept. Sleep Breath. 2020 Sep;24(3):1229-1236. doi: 10.1007/s11325-020-02045-w. Epub 2020 Mar 11.
PubMed 32162278
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superimposition of Intra-oral Scans in Mandibular Advancement Device (MAD) Therapy for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06612008
- Acronym / sponsor ID
- SIMT-OSA / 202401
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Obstructive Sleep Apnea Syndrome, Oral Appliance Therapy, Mandibular Advancement Device
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 25 Sep 2024 (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.
Obstructive Sleep Apnea (OSA) affects quality of life and health. Mandibular Advancement Devices (MAD) can help with OSA but may cause dental and jaw changes. This study uses a new 3D scanning method to track these changes and compare two adjustment methods for MAD to find the best approach for patients.
Goals:
- To track dental and jaw changes in OSA patients using 3D scans.
- To assess the impact of MAD on quality of life and cognitive function.
Study Details:
The aim of the study is to follow OSA patients at multiple centers over several years, comparing two MAD adjustment methods. Participants will undergo routine fitting and imaging.
Outcome:
The study aims to reduce dental and jaw changes and to improve MAD treatment and patient outcomes.
Detailed description
Rationale: Obstructive Sleep Apnea (OSA) significantly reduces quality of life and increases the risk of severe health issue. While Mandibular Advancement Devices (MAD) are effective in managing OSA symptoms, they often introduce undesirable dental and skeletal changes, which can have a negative impact on patient satisfaction. Recognizing this issue, this study hypothesizes that using an innovative 3D superimposition technique to track these changes will allow to compare two different titration protocols more precisely and determine the optimal approach for various patient groups. By identifying the most effective titration protocol, the aim is to enhance treatment adherence and treatment success, addressing a critical gap in existing literature and significantly improving patient outcomes in OSA treatment.
Objective:
- Investigate dental and skeletal changes in OSA patients undergoing MAD treatment using an innovative 3D superimposition technique.
- Assess the impact of MAD treatment on quality of life (QoL) and cognitive function.
Study design: A prospective multicentre observational cohort study will be conducted, involving four screening points: at the study's onset and during the first, second, and third annual follow-up assessments. This investigation will involve two patient cohorts undergoing different titration approaches: orthodontic titration and another commonly used titration protocol.
Study population: The study will include adults with mild to moderate OSA who will undergo MAD treatment.
Intervention: Participants will be fitted with a MAD as part of their routine clinical care. The intervention involves the collection of baseline intra-oral scans (IOS), lateral cephalograms (LCR), orthopantomograms (OPT), and a collection of orthodontic parameters. These assessments will be repeated at each follow-up appointment.
Main study parameters/endpoints:
- Dental and skeletal changes tracked over time using intra-oral scans (IOS), lateral cephalograms (LCR), orthopantomograms (OPT), and complete orthodontic evaluations.
- Changes in quality of life (QoL) and cognitive function assessed through validated questionnaires.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will experience the routine procedure of MAD fitting and imaging assessments. The study's positive outcomes encompass advancing the knowledge of the enduring impacts of MAD treatment on oral health. Participants will not incur any additional risks by engaging in this research, as it solely involves additional routine diagnostic procedures. The study is group-related, focusing on OSA patients undergoing MAD therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepwise titration | – | Device: Mandibular Advancement DevicePatients will receive a MAD with an individualized stepwise titration protocol. Initially, the device is set at 60% advancement of the maximum protrusion. Over the first 3 months, the advancement is adjusted incrementally (to 75% or 90%) based on subjective improvement in OSA symptoms and side effects. If side effects occur, the advancement is decreased. |
| Personalized titration | – | Device: Mandibular Advancement DevicePatients will receive a MAD set to baseline settings. Instead of following a standard titration process, personalized titration will use both objective data and subjective patient feedback to determine the optimal advancement. This approach takes into account individual factors such as the patient's oral anatomy, sleep study results, and specific symptoms. The goal is to achieve a personalized, optimal setting that maximizes symptom improvement and comfort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants of the research will be recruited from the Department of Oral and Maxillofacial Surgery at 'Isala Hospital Zwolle' and from the orthodontic practice 'Orthodontisten Heemstede', both located in the Netherlands.
Key inclusion criteria (4 listed)
- Adults ≥ 18 years of age
- Patients with a diagnosis of OSA
- Patients with an apnea-hypopnea index (AHI) of 5 until 30 events per hour
- Patients initially treated with MAD
Key exclusion criteria (12 listed)
- Patients under 18 years of age
- Patients without a diagnosis of mild to moderate OSA
- Patients undergoing other treatments for OSA
- Patients previously undergone MAD treatment (this also includes over the counter boil and bite MADs)
- Patients diagnosed with central sleep apnea
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 DeviceMADs are custom-fitted oral appliances designed to reposition the mandible (lower jaw) forward during sleep, which helps to keep the airway open by preventing upper airway collapse. | Device | Personalized titration, Stepwise titration |
Primary outcome
Dental occlusal measurements
Time frame: Baseline; Year 1; Year 2; Year 3
* Overbite (mm): the vertical overlap of the upper and lower teeth. * Overjet (mm): the horizontal overlap of the upper and lower teeth. * Maximal protrusion (mm): the most protrusive position of the mandible, independent of tooth contact. * Maximal retrusion (mm): the most retrusive position of the mandible, independent of tooth contact. * Protrusive range (mm): the distance between the most protrusive and most retrusive position of the mandible. * Maximal mouth opening (mm): the maximum distance between the upper and lower incisors when the mouth is fully opened.
Molar and canine relationships
Time frame: Baseline; Year 1; Year 2; Year 3
* Molar relationships (in premolar width equivalents): the relative position of the upper and lower molars. * Canine relationships (in premolar width equivalents): the relative position of the upper and lower canines.
History of orthodontic treatment
Time frame: Baseline; Year 1; Year 2; Year 3
• Previous orthodontic treatment (braces/ premolar extractions)
3 secondary outcomes
Cephalometric dentofacial measurements
Time frame: Baseline; Year 1; Year 2; Year 3
Cephalometric facial and mandibular measurements
Time frame: Baseline; Year 1; Year 2; Year 3
Cephalometric ratios and divergence
Time frame: Baseline; Year 1; Year 2; Year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Background: PubMed 32162278de Ruiter MHT, Aarab G, de Vries N, Lobbezoo F, de Lange J. A stepwise titration protocol for oral appliance therapy in positional obstructive sleep apnea patients: proof of concept. Sleep Breath. 2020 Sep;24(3):1229-1236. doi: 10.1007/s11325-020-02045-w. Epub 2020 Mar 11.
- Related InfoLink provided by the sponsor.
- 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.
J. de Lange, Prof. Dr. principal investigator
Amsterdam University Medical Center
J.P.T.F. Ho, Dr. principal investigator
Amsterdam University Medical Center
N.C.W. van der Kaaij, Dr. principal investigator
Amsterdam University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Amsterdam UMC, location VUmc.
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 12 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: opening soon, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A. el Khalfioui, Bsc (0684900593, a.elkhalfioui@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental occlusal measurements (time frame: Baseline; Year 1; Year 2; Year 3). The study lists 3 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 NCT06612008, 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 10 Jul 2025.