Apnea, ObstructiveMRA OSANCT06810479
A Study Comparing Two Mandibular Advancement Devices in the Treatment of Sleep Apnea
A study testing Polygraphy, Questionaire and Question in people with Apnea, Obstructive, run by Ziekenhuis Oost-Limburg at 1 site in Belgium.
Trial summary
The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Obstructive
- What is being tested?
- Polygraphy, Questionaire and Question
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 21 Mar 2025to 6 Mar 2026
- 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
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Provide signed and dated informed consent
- Males or females aged 18 and above
- Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous surgery on the upper airways
- Prior treatment of OSA (CPAP or MRA)
- Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders
- Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)
- Presence of temporomandibular joint dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea
The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.
Patiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.
Read the detailed description
A mandibular repositioning appliance (MRA) is the primary treatment option for patients with mild to moderate obstructive sleep apnea (OSA), as well as for those with severe OSA who are intolerant to continuous positive airway pressure (CPAP) therapy or for whom surgical interventions are not viable. MRAs function by advancing the mandible, thereby increasing the volume of the upper airway and reducing its tendency to collapse during sleep. Various types of MRAs are available, and multiple classification systems can be employed to distinguish between these different types.
Mandibular repositioning appliances (MRAs) can be either custom-made or universal. Custom-made devices, which are typically more expensive, are fabricated in a dental laboratory using dental impressions. In contrast, prefabricated devices, often thermoplastic MRAs, are generally less costly and readily available over the counter.
Mandibular repositioning appliances (MRAs) can be classified as non-titratable, also known as monoblock devices, which have a fixed position, or titratable devices, which allow for gradual adjustment of the mandibular position until the desired therapeutic effect is achieved. Current guidelines recommend the use of titratable MRAs.
Titratable mandibular repositioning appliances (MRAs) can be further categorized into two types: midline traction devices, where the upper and lower components are connected at the front of the device, and bilateral thrust devices, where the upper and lower components are linked in the lateral or (pre-)molar regions.
Within the latter category, various designs exist, including devices that are adjustable on both sides using Hyrax screws and 3D-printed devices equipped with a series of lower components that allow for adjustments in mandibular position.
An example of an MRA adjustable with Hyrax screws is the SomnoDent® device (SomnoMed, Denton, Texas, USA). An example of a device utilizing a series of lower components for titration is the OrthoApnea appliance (ORTHOAPNEA S.L., Málaga, Spain), which features a specific attachment mechanism.
Although studies have already been published comparing different types of "bilateral thrust" devices, no studies to date have directly compared the categories mentioned above. The hypothesis of the investigators is that both appliances have similar effectiveness in the treatment of mild-to-moderate obstructive sleep apnea.
Primary objective:
Improvement of AHI, measured by polygraphy before treatment and after treatment with each MRA.
Secondary objective;
- Peripheral oxygen saturation, measured by polygraphy before treatment and after treatment with each MRA
- Average saturation
- Lowest saturation
- Oxygen desaturation index >3% (events/h)
- Total duration with saturation < 90%
- Epworth Sleepiness Scale, taken before treatment and after treatment with each MRA
- Patient experience questionnaire, taken before treatment and after treatment with each MRA
- Patient final choice of preferred MRA
Endpoints:
The investigators assess the objective improvement in OSA by comparing polygraphy results taken before and after treatment with each MRA. To evaluate the subjective effects of the MRA, the investigators compare the scores from the Epworth Sleepiness Scale. The participants subjective experience with each MRA type is measured using a patient experience questionnaire, along with noting the final preference for device type of the participants.
Study design:
- Randomized, controlled cross-over study
- Study population: Patients referred to the Department of Oral and Maxillofacial Surgery at ZOL Genk for Mandibular Repositioning Appliance (MRA) therapy, aged 18 years or older diagnosed with an Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour.
Inclusion criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Provide signed and dated informed consent
- Males or females aged 18 and above
- Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography
Exclusion criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous surgery on the upper airways
- Prior treatment of OSA (CPAP or MRA)
- Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders
- Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)
- Presence of temporomandibular joint dysfunction
- Conditions
- Apnea, Obstructive
- Being tested
- Polygraphy, Questionaire, Question
- Keywords
- sleep apnea, MRA, mandibular repositioning appliance
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolygraphyDiagnostic test
Polygraphy after 3 months of use of each appliance: an unattended home sleep study at the end of the first treatment period, and in-hospital polygraphy at the end of the second treatment period.
QuestionaireOther
Epworth Sleepiness Scale
- Johns, Murray W. "A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale." Sleep, vol. 14, no. 6, 1991, pp. 540-545.
QuestionaireOther
Patient experience questionnaire
- Ng, E.T., Perez-Garcia, A., en Lagravère-Vich, M.O. "Development and Initial Validation of a Questionnaire to Measure Patient Experience with Oral Appliance Therapy." Journal of Clinical Sleep Medicine, vol. 19, nr. 8, 1 aug. 2023, pp. 1437-1445. doi: 10.5664/jcsm.10562. PMID: 37082817; PMCID: PMC10394373
QuestionOther
Patient final choice of preferred MRA
| Study group | Role | What they receive |
|---|---|---|
| MRA1MRA2 | Experimental | Use of MRA device 1 for 3 months, use of MRA device 2 for 3 months Receives: Diagnostic Test: Polygraphy; Other: Questionaire; Other: Question |
| MRA2MRA1 | Experimental | Use of MRA device 2 for 3 months, use of MRA device 1 for 3 months Receives: Diagnostic Test: Polygraphy; Other: Questionaire; Other: Question |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Improvement of AHI (apnea-hypopnea index), measured by polygraphy before treatment and after treatment with each MRA. The goal of the mandibular advancement device is to reduce the number of apneas and hypopneas per hour, apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked, causing shallow breathing. This is measured by a polygraphy-test overnight at the patiënts home.
Measured: 3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)
Secondary outcomes (6)
Peripheral oxygen saturation 1
Measured by polygraphy
- Average saturation (measured in %)
- Lowest saturation (measured in %)
Oxygen saturation in percent is the fraction of oxygen-saturated haemoglobin relative to total haemoglobin (unsaturated + saturated) in the blood * 100%
Measured: 3 monthts after use of first MRA, 3 months after use of second MRA
Peripheral oxygen saturation 2
Measured by polygraphy
- Oxygen desaturation index >3% (events/h)
Desaturation episodes are defined as a decrease in the mean oxygen saturation of ≥3% for more than 10 seconds per hour
Measured: 3 monthts after use of first MRA, 3 months after use of second MRA
Peripheral oxygen saturation 3
Measured by polygraphy
- Total duration with saturation < 90%
The percentage of cumulative time with oxygen saturation below 90% in total sleep time.
Measured: 3 monthts after use of first MRA, 3 months after use of second MRA
ESS
Epworth Sleepiness Scale (questionaire)
The minimum value is 0 and the maximum value is 24. A higher score means a worse outcome, indicating more excessive daytime sleepiness.
The Epworth Sleepiness Scale is scored by adding up the individual scores for each of the eight questions. Each question is rated on a scale of 0 to 3, with 0 being "no chance of dozing" and 3 being "high chance of dozing." ter daytime sleepiness.
Score range Interpretation 0-5 Lower normal daytime sleepiness 6-10 Normal daytime sleepiness 11-12 Mild excessive daytime sleepiness 13-15 Moderate excessive daytime sleepiness 16-24 Severe excessive daytime sleepiness
Measured: 3 monthts after use of first MRA, 3 months after use of second MRA
Patient experience questionnaire
Patient experience with each appliance, assessed after 3 months of use. The appliance-design domain of the Oral Appliance Therapy Patient Experience Questionnaire (OATPEQ; Ng et al., J Clin Sleep Med 2023) was used, translated into Dutch. It comprises 13 statements, each scored from 0 to 4, giving a total score ranging from 0 to 52. A higher score indicates a more positive patient experience.
Measured: 3 months after use of the first MRA, 3 months after use of the second MRA
Final choice
Patient final choice of preferred MRA.
At the final visit, after using each MRA (type 1 and type 2) for three months (with a two-week washout period in between), the patient will choose their preferred device. The final choice will be noted down after oral questioning.
Measured: after the use of each MRA for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start21 Mar 2025
- Primary completion6 Mar 2026
- Study completion6 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- randomised, controlled cross over study comparing two mandibular advancement devices
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810479
- Sponsor's protocol ID
- Z-2025015
- Acronym
- MRA OSA
- Status last verified
- Aug 2026
- First submitted
- 24 Jan 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng ET, Perez-Garcia A, Lagravere-Vich MO. Development and initial validation of a questionnaire to measure patient experience with oral appliance therapy. J Clin Sleep Med. 2023 Aug 1;19(8):1437-1445. doi: 10.5664/jcsm.10562.
PubMed 37082817Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
PubMed 1798888Zhou J, Liu YH. A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. J Oral Rehabil. 2012 Dec;39(12):914-22. doi: 10.1111/joor.12006. Epub 2012 Sep 27.
PubMed 23016888Vezina JP, Blumen MB, Buchet I, Hausser-Hauw C, Chabolle F. Does propulsion mechanism influence the long-term side effects of oral appliances in the treatment of sleep-disordered breathing? Chest. 2011 Nov;140(5):1184-1191. doi: 10.1378/chest.10-3123. Epub 2011 May 26.
PubMed 21622552Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial. Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17.
PubMed 36928350Lawton HM, Battagel JM, Kotecha B. A comparison of the Twin Block and Herbst mandibular advancement splints in the treatment of patients with obstructive sleep apnoea: a prospective study. Eur J Orthod. 2005 Feb;27(1):82-90. doi: 10.1093/ejo/cjh067.
PubMed 15743867Uniken Venema JAM, Rosenmoller BRAM, de Vries N, de Lange J, Aarab G, Lobbezoo F, Hoekema A. Mandibular advancement device design: A systematic review on outcomes in obstructive sleep apnea treatment. Sleep Med Rev. 2021 Dec;60:101557. doi: 10.1016/j.smrv.2021.101557. Epub 2021 Oct 1.
PubMed 34662769Schmidt-Nowara W, Lowe A, Wiegand L, Cartwright R, Perez-Guerra F, Menn S. Oral appliances for the treatment of snoring and obstructive sleep apnea: a review. Sleep. 1995 Jul;18(6):501-10. doi: 10.1093/sleep/18.6.501.
PubMed 7481421Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.
PubMed 31717429Almeida FR, Lowe AA. Principles of oral appliance therapy for the management of snoring and sleep disordered breathing. Oral Maxillofac Surg Clin North Am. 2009 Nov;21(4):413-20. doi: 10.1016/j.coms.2009.07.002.
PubMed 19944341Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.
PubMed 26094920
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Cross Over Study Comparing Two Mandibular Advancement Devices in the Treatment of Mild-to-moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06810479
- Acronym / sponsor ID
- MRA OSA / Z-2025015
- Conditions
- Apnea, Obstructive
- Keywords
- sleep apnea, MRA, mandibular repositioning appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 Mar 2026 (actual)
- First posted
- 5 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.
The goal of this randomised, controlled cross-over study is to compare two mandibular repositioning devices (MRA) already on the market in the treatment of mild-to-moderate obstructive sleep apnea.
Patiënt will test the first MRA for 3 months, after a wash out period of 2 weeks they will test the second MRA for 3 months. It will be randomised what type of MRA will be tested first and second.
Detailed description
A mandibular repositioning appliance (MRA) is the primary treatment option for patients with mild to moderate obstructive sleep apnea (OSA), as well as for those with severe OSA who are intolerant to continuous positive airway pressure (CPAP) therapy or for whom surgical interventions are not viable. MRAs function by advancing the mandible, thereby increasing the volume of the upper airway and reducing its tendency to collapse during sleep. Various types of MRAs are available, and multiple classification systems can be employed to distinguish between these different types.
Mandibular repositioning appliances (MRAs) can be either custom-made or universal. Custom-made devices, which are typically more expensive, are fabricated in a dental laboratory using dental impressions. In contrast, prefabricated devices, often thermoplastic MRAs, are generally less costly and readily available over the counter.
Mandibular repositioning appliances (MRAs) can be classified as non-titratable, also known as monoblock devices, which have a fixed position, or titratable devices, which allow for gradual adjustment of the mandibular position until the desired therapeutic effect is achieved. Current guidelines recommend the use of titratable MRAs.
Titratable mandibular repositioning appliances (MRAs) can be further categorized into two types: midline traction devices, where the upper and lower components are connected at the front of the device, and bilateral thrust devices, where the upper and lower components are linked in the lateral or (pre-)molar regions.
Within the latter category, various designs exist, including devices that are adjustable on both sides using Hyrax screws and 3D-printed devices equipped with a series of lower components that allow for adjustments in mandibular position.
An example of an MRA adjustable with Hyrax screws is the SomnoDent® device (SomnoMed, Denton, Texas, USA). An example of a device utilizing a series of lower components for titration is the OrthoApnea appliance (ORTHOAPNEA S.L., Málaga, Spain), which features a specific attachment mechanism.
Although studies have already been published comparing different types of "bilateral thrust" devices, no studies to date have directly compared the categories mentioned above. The hypothesis of the investigators is that both appliances have similar effectiveness in the treatment of mild-to-moderate obstructive sleep apnea.
Primary objective:
Improvement of AHI, measured by polygraphy before treatment and after treatment with each MRA.
Secondary objective;
- Peripheral oxygen saturation, measured by polygraphy before treatment and after treatment with each MRA
- Average saturation
- Lowest saturation
- Oxygen desaturation index >3% (events/h)
- Total duration with saturation < 90%
- Epworth Sleepiness Scale, taken before treatment and after treatment with each MRA
- Patient experience questionnaire, taken before treatment and after treatment with each MRA
- Patient final choice of preferred MRA
Endpoints:
The investigators assess the objective improvement in OSA by comparing polygraphy results taken before and after treatment with each MRA. To evaluate the subjective effects of the MRA, the investigators compare the scores from the Epworth Sleepiness Scale. The participants subjective experience with each MRA type is measured using a patient experience questionnaire, along with noting the final preference for device type of the participants.
Study design:
- Randomized, controlled cross-over study
- Study population: Patients referred to the Department of Oral and Maxillofacial Surgery at ZOL Genk for Mandibular Repositioning Appliance (MRA) therapy, aged 18 years or older diagnosed with an Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour.
Inclusion criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Provide signed and dated informed consent
- Males or females aged 18 and above
- Apnea-Hypopnea Index (AHI) between 5 and 30 events per hour diagnosed by a polysomnography
Exclusion criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Previous surgery on the upper airways
- Prior treatment of OSA (CPAP or MRA)
- Presence of unstable cardiovascular conditions, neurological, mental, or psychiatric disorders
- Insufficient dental or periodontal condition for a mandibular repositioning appliance (MRA)
- Presence of temporomandibular joint dysfunction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomised, controlled cross over study comparing two mandibular advancement devices
| Arm | Type | Receives |
|---|---|---|
| MRA1MRA2 | Experimental | Diagnostic Test: Polygraphy, Other: Questionaire, Other: QuestionUse of MRA device 1 for 3 months, use of MRA device 2 for 3 months |
| MRA2MRA1 | Experimental | Diagnostic Test: Polygraphy, Other: Questionaire, Other: QuestionUse of MRA device 2 for 3 months, use of MRA device 1 for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PolygraphyPolygraphy after 3 months of use of each appliance: an unattended home sleep study at the end of the first treatment period, and in-hospital polygraphy at the end of the second treatment period. | Diagnostic test | MRA1MRA2, MRA2MRA1 |
| QuestionaireEpworth Sleepiness Scale o Johns, Murray W. "A New Method for Measuring Daytime Sleepiness: The Epworth Sleepiness Scale." Sleep, vol. 14, no. 6, 1991, pp. 540-545. | Other | MRA1MRA2, MRA2MRA1 |
| QuestionairePatient experience questionnaire o Ng, E.T., Perez-Garcia, A., en Lagravère-Vich, M.O. "Development and Initial Validation of a Questionnaire to Measure Patient Experience with Oral Appliance Therapy." Journal of Clinical Sleep Medicine, vol. 19, nr. 8, 1 aug. 2023, pp. 1437-1445. doi: 10.5664/jcsm.10562. PMID: 37082817; PMCID: PMC10394373 | Other | MRA1MRA2, MRA2MRA1 |
| QuestionPatient final choice of preferred MRA | Other | MRA1MRA2, MRA2MRA1 |
Primary outcome
AHI
Time frame: 3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)
Improvement of AHI (apnea-hypopnea index), measured by polygraphy before treatment and after treatment with each MRA. The goal of the mandibular advancement device is to reduce the number of apneas and hypopneas per hour, apneas are periods when a person stops breathing and hypopneas are instances where airflow is blocked, causing shallow breathing. This is measured by a polygraphy-test overnight at the patiënts home.
6 secondary outcomes
Peripheral oxygen saturation 1
Time frame: 3 monthts after use of first MRA, 3 months after use of second MRA
Peripheral oxygen saturation 2
Time frame: 3 monthts after use of first MRA, 3 months after use of second MRA
Peripheral oxygen saturation 3
Time frame: 3 monthts after use of first MRA, 3 months after use of second MRA
ESS
Time frame: 3 monthts after use of first MRA, 3 months after use of second MRA
Patient experience questionnaire
Time frame: 3 months after use of the first MRA, 3 months after use of the second MRA
Final choice
Time frame: after the use of each MRA for 3 months
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 11 Aug 2026.
- Results publication: PubMed 37082817Ng ET, Perez-Garcia A, Lagravere-Vich MO. Development and initial validation of a questionnaire to measure patient experience with oral appliance therapy. J Clin Sleep Med. 2023 Aug 1;19(8):1437-1445. doi: 10.5664/jcsm.10562.
- Results publication: PubMed 1798888Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.
- Results publication: PubMed 23016888Zhou J, Liu YH. A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. J Oral Rehabil. 2012 Dec;39(12):914-22. doi: 10.1111/joor.12006. Epub 2012 Sep 27.
- Results publication: PubMed 21622552Vezina JP, Blumen MB, Buchet I, Hausser-Hauw C, Chabolle F. Does propulsion mechanism influence the long-term side effects of oral appliances in the treatment of sleep-disordered breathing? Chest. 2011 Nov;140(5):1184-1191. doi: 10.1378/chest.10-3123. Epub 2011 May 26.
- Results publication: PubMed 36928350Shi X, Lobbezoo F, Chen H, Rosenmoller BRAM, Berkhout E, de Lange J, Aarab G. Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial. Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17.
- Results publication: PubMed 15743867Lawton HM, Battagel JM, Kotecha B. A comparison of the Twin Block and Herbst mandibular advancement splints in the treatment of patients with obstructive sleep apnoea: a prospective study. Eur J Orthod. 2005 Feb;27(1):82-90. doi: 10.1093/ejo/cjh067.
- Results publication: PubMed 34662769Uniken Venema JAM, Rosenmoller BRAM, de Vries N, de Lange J, Aarab G, Lobbezoo F, Hoekema A. Mandibular advancement device design: A systematic review on outcomes in obstructive sleep apnea treatment. Sleep Med Rev. 2021 Dec;60:101557. doi: 10.1016/j.smrv.2021.101557. Epub 2021 Oct 1.
- Results publication: PubMed 7481421Schmidt-Nowara W, Lowe A, Wiegand L, Cartwright R, Perez-Guerra F, Menn S. Oral appliances for the treatment of snoring and obstructive sleep apnea: a review. Sleep. 1995 Jul;18(6):501-10. doi: 10.1093/sleep/18.6.501.
- Results publication: PubMed 31717429Dieltjens M, Vanderveken O. Oral Appliances in Obstructive Sleep Apnea. Healthcare (Basel). 2019 Nov 8;7(4):141. doi: 10.3390/healthcare7040141.
- Results publication: PubMed 19944341Almeida FR, Lowe AA. Principles of oral appliance therapy for the management of snoring and sleep disordered breathing. Oral Maxillofac Surg Clin North Am. 2009 Nov;21(4):413-20. doi: 10.1016/j.coms.2009.07.002.
- Results publication: PubMed 26094920Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygraphy, Questionaire and Question in people with Apnea, Obstructive, run by Ziekenhuis Oost-Limburg 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?
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 11 Aug 2026. 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?
AHI (time frame: 3 monthts after use of first MRA (mandibular advancement device), 3 months after use of second MRA (mandibular advancement device)). 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 NCT06810479, which also lists 11 linked publications.
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 11 Aug 2026.