Obstructive Sleep ApneaSUNRISE-ORTHONCT07910461
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
An observational study of Obstructive Sleep Apnea and Sleep Apnea, Obstructive, run by CHR Sambre et Meuse Site Meuse at 1 site in Belgium.
Trial summary
Orthognathic surgery changes the skeletal framework of the upper airway, but its functional effect on sleep-disordered breathing remains poorly documented, particularly with respect to respiratory effort. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea, Obstructive, Dentofacial Deformities
- What is being tested?
- Orthognathic surgery (BSSO with or without Le Fort I osteotomy), Sunrise mandibular jaw movement monitoring and Facial multidetector CT in natural head position
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Nov 2026to 15 Sep 2027
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients aged 15 years or older referred to the maxillofacial surgery department of CHR Sambre et Meuse, Meuse site (Namur, Belgium), and scheduled for orthognathic surgery after orthodontic-surgical multidisciplinary assessment.
Who may be able to join
- Dentoskeletal deformity requiring bilateral sagittal split osteotomy with or without Le Fort I osteotomy after orthodontic-maxillofacial multidisciplinary assessment.
- Age 15 years or older at consent, with completed skeletal growth according to department practice.
- Positive two-step screening for sleep-disordered breathing risk: (1) STOP-BANG score >= 3 and/or high risk on the Berlin questionnaire; and (2) on the first Sunrise night at 1 month before surgery, AHI >= 5 events/h or REMOV >= 15% of total sleep time.
- Signed informed consent (co-signed by holders of parental authority for minors). - Ability to use the Sunrise device at home.
Who cannot join
- Medical or anesthetic contraindication to orthognathic surgery.
- Known severe sleep-disordered breathing (AHI >= 30/h) treated preoperatively with CPAP or a mandibular advancement device.
- Syndromic craniofacial malformation (e.g., Crouzon syndrome, Pierre Robin sequence).
- Known allergy or skin intolerance to the Sunrise sensor materials or adhesive, or active dermatosis of the submental area.
- Current pregnancy or breastfeeding.
- Concurrent participation in another interventional study likely to interfere with sleep measurements or surgical outcomes.
- Inability to comply with the planned visits and procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
CHR Sambre et Meuse - Site Meuse, Avenue Albert Ier 185, Namur, 5000, Belgium
Namur, Namur, 5100
Jerome Decaux, MD, 0032474523674, jerome.decaux@chrsm.be
About this study
Official title: Effects of Orthognathic Surgery on Respiratory Effort Burden in Obstructive Sleep Apnea Assessed by Indices Derived From Mandibular Jaw Movement Monitoring: A Prospective Exploratory Single-Center Pilot Study (SUNRISE-ORTHO-NAMUR)
Orthognathic surgery changes the skeletal framework of the upper airway, but its functional effect on sleep-disordered breathing remains poorly documented, particularly with respect to respiratory effort. This prospective, exploratory, single-center pilot study will describe changes in the apnea-hypopnea index (AHI) and in respiratory effort burden (REMOV, percentage of total sleep time with increased respiratory effort) measured with the Sunrise mandibular jaw movement (MJM) home sleep monitoring device, from 1 month before to 6 months after orthognathic surgery (bilateral sagittal split osteotomy with or without Le Fort I osteotomy). Twenty-five patients aged 15 years or older, scheduled for orthognathic surgery as part of standard care at CHR Sambre et Meuse (Namur, Belgium) and screened positive for sleep-disordered breathing risk, will be included. Results will be used to generate hypotheses and to size a future confirmatory study.
Read the detailed description
Design: prospective, exploratory, single-center, non-randomized cohort without control group. Surgery is indicated and performed as part of standard care and is not assigned by the protocol; the study adds standardized measurements before and after surgery. Screening and inclusion (two steps): (1) STOP-BANG score >= 3 and/or high risk on the Berlin questionnaire; (2) only if step 1 is positive, a first Sunrise night at 1 month before surgery (T-1 month), considered positive if AHI >= 5 events/h OR REMOV >= 15% of total sleep time. Both steps must be positive for inclusion. The 15% REMOV threshold is an operational screening threshold chosen for this study and is not a validated cut-off. Schedule: T-1 month: virtual surgical planning (IPS CaseDesigner) from intraoral scans, facial multidetector CT in natural head position, clinical parameters, two consecutive Sunrise nights and questionnaires (STOP-BANG, Berlin, ESS, FSS, FOSQ-10, SF-12, EQ-5D-5L). Day 0: bilateral sagittal split osteotomy with or without Le Fort I osteotomy, mandible-first sequence, single surgeon. Postoperative visits at 1 week and 4 weeks. T+6 months: facial CT in natural head position, postoperative virtual analysis, two consecutive Sunrise nights and the same questionnaires. Sample size: 25 participants, based on pilot study recommendations (Sim \& Lewis; Whitehead et al.). Assuming a mean AHI change of about 5 events/h and a standard deviation of 7 events/h, 25 patients provide a 95% confidence interval of approximately +/- 3 events/h around the mean change. Analysis: descriptive and exploratory; paired comparisons between T-1 month and T+6 months; exploratory association between surgical movements and changes in AHI/REMOV. Data are collected on paper source documents and a pseudonymized Excel database at the study site.
- Being tested
- Orthognathic surgery (BSSO with or without Le Fort I osteotomy), Sunrise mandibular jaw movement monitoring, Facial multidetector CT in natural head position
- Keywords
- orthognathic surgery, bilateral sagittal split osteotomy, Lefort 1 osteotomy, home sleep apnea testing, respiratory effort, apnea-hypopnea index, mandibular jaw movement, upper airway volume
- Medical subject headings
- Sleep Apnea, Obstructive, Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic surgery (BSSO with or without Le Fort I osteotomy)Procedure or surgery
Standard-of-care orthognathic surgery under general anesthesia, mandible-first sequence, planned with 3D virtual surgical planning (IPS CaseDesigner, KLS Martin) and in-house printed splints. Not assigned by the study protocol.
Sunrise mandibular jaw movement monitoringDevice
Chin-mounted MJM sensor (Sunrise, Namur, Belgium) used at home for two consecutive nights before surgery and two consecutive nights 6 months after surgery to derive respiratory and sleep indices.
Facial multidetector CT in natural head positionDiagnostic test
Facial CT at 1 month before and 6 months after surgery for 3D upper airway volume analysis; field restricted to the facial skeleton, dose optimized.
| Study group | Role | What they receive |
|---|---|---|
| Orthognathic surgery cohort | Patients aged 15 years or older scheduled for bilateral sagittal split osteotomy with or without Le Fort I osteotomy as part of standard care, with positive two-step screening for sleep-disordered breathing risk. Sunrise monitoring (2 nights) and facial CT are performed 1 month before and 6 months after surgery. Receives: Procedure: Orthognathic surgery (BSSO with or without Le Fort I osteotomy); Device: Sunrise mandibular jaw movement monitoring; Diagnostic Test: Facial multidetector CT in natural head position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apnea-hypopnea index (AHI) measured by mandibular jaw movement monitoring
AHI (events/h) measured with the Sunrise device; absolute change (T+6 months minus T-1 month) and relative change (%). Only absolute change is reported if baseline AHI < 1 event/h.
Measured: From 1 month before surgery (baseline) to 6 months after surgery
Change in respiratory effort burden (REMOV)
Percentage of total sleep time with increased respiratory effort (REMOV, %TST) measured with the Sunrise device; absolute change (percentage points) and relative change (%). Only absolute change is reported if baseline REMOV < 5% TST.
Measured: From 1 month before surgery (baseline) to 6 months after surgery
Secondary outcomes (11)
Change in Oxygen Desaturation Index (ODI)
Number of oxygen desaturation events per hour of sleep (events/h), recorded during home sleep testing with the Sunrise system. This is a physiological index, not a scale score; higher values indicate more severe nocturnal hypoxemia (worse outcome).
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Respiratory Effort-Related Arousal (RERA) Index
Number of respiratory effort-related arousals per hour of sleep (events/h), derived from mandibular jaw movement analysis by the Sunrise system. This is a physiological index, not a scale score; higher values indicate worse sleep-disordered breathing.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Sleep Onset Latency
Time from lights-off to sleep onset (minutes), measured by the Sunrise system. Not a scale score; higher values indicate worse sleep initiation.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Wake After Sleep Onset (WASO)
Total time awake after sleep onset (minutes), measured by the Sunrise system. Not a scale score; higher values indicate worse sleep continuity.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Sleep Fragmentation Index
Number of awakenings and sleep-stage shifts per hour of sleep (events/h), measured by the Sunrise system. Not a scale score; higher values indicate more fragmented sleep (worse outcome).
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Change in STOP-BANG Questionnaire Score
STOP-BANG questionnaire (Snoring, Tiredness, Observed apnea, high blood Pressure, Body mass index, Age, Neck circumference, Gender). Total score ranges from 0 to 8; higher scores indicate a higher risk of obstructive sleep apnea (worse outcome).
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Percentage of Participants Classified as High Risk on the Berlin Questionnaire
Berlin Questionnaire for sleep apnea risk, with three symptom categories; participants are classified as high risk if two or more categories are positive. Reported as the percentage of participants at high risk; a higher percentage indicates a worse outcome.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Mandibular Advancement and Change in AHI
Spearman's rank correlation coefficient between (1) achieved mandibular anteroposterior advancement in millimeters, measured at B point by superimposition of preoperative and 6-month postoperative facial CT scans in IPS CaseDesigner, and (2) change in apnea-hypopnea index (events/h) measured by the Sunrise system between baseline and 6 months.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Maxillary Advancement and Change in AHI
Spearman's rank correlation coefficient between (1) achieved maxillary anteroposterior advancement in millimeters, measured at B point by superimposition of preoperative and 6-month postoperative facial CT scans in IPS CaseDesigner, and (2) change in apnea-hypopnea index (events/h) measured by the Sunrise system between baseline and 6 months.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Mandibular Advancement and Change in REMOV
Spearman's rank correlation coefficient between (1) achieved mandibular anteroposterior advancement in millimeters, measured at B point by superimposition of preoperative and 6-month postoperative facial CT scans in IPS CaseDesigner, and (2) change in percentage of total sleep time with increased respiratory effort (REMOV, %) measured by the Sunrise system between baseline and 6 months.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Maxillary Advancement and Change in REMOV
Spearman's rank correlation coefficient between (1) achieved maxillary anteroposterior advancement in millimeters, measured at B point by superimposition of preoperative and 6-month postoperative facial CT scans in IPS CaseDesigner, and (2) change in percentage of total sleep time with increased respiratory effort (REMOV, %) measured by the Sunrise system between baseline and 6 months.
Measured: From 1 month before surgery (baseline) to 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start4 Nov 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (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.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHR Sambre et Meuse Site Meuse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Decaux Jerome, CHR Sambre et Meuse Site Meuse
- Investigators
- jerome decaux, MD, Principal investigator, CHR Sambre et Meuse - Site Meuse, Avenue Albert Ier 185, Namur, 5000, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910461
- Sponsor's protocol ID
- sunrise-ortho-namur/2026-353
- Other IDs
- B7072026000061
- Acronym
- SUNRISE-ORTHO
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team, in accordance with the informed consent and the EU General Data Protection Regulation. Aggregated results will be published.
Publications
Zaghi S, Holty JE, Certal V, Abdullatif J, Guilleminault C, Powell NB, Riley RW, Camacho M. Maxillomandibular Advancement for Treatment of Obstructive Sleep Apnea: A Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2016 Jan;142(1):58-66. doi: 10.1001/jamaoto.2015.2678.
PubMed 26606321
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Orthognathic Surgery on Respiratory Effort Burden in Obstructive Sleep Apnea Assessed by Indices Derived From Mandibular Jaw Movement Monitoring: A Prospective Exploratory Single-Center Pilot Study (SUNRISE-ORTHO-NAMUR)
- ClinicalTrials.gov ID
- NCT07910461
- Acronym / sponsor ID
- SUNRISE-ORTHO / sunrise-ortho-namur/2026-353
- Keywords
- orthognathic surgery, bilateral sagittal split osteotomy, Lefort 1 osteotomy, home sleep apnea testing, respiratory effort, apnea-hypopnea index, mandibular jaw movement, upper airway volume
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- CHR Sambre et Meuse Site MeuseUniversity, hospital or other
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
Orthognathic surgery changes the skeletal framework of the upper airway, but its functional effect on sleep-disordered breathing remains poorly documented, particularly with respect to respiratory effort. This prospective, exploratory, single-center pilot study will describe changes in the apnea-hypopnea index (AHI) and in respiratory effort burden (REMOV, percentage of total sleep time with increased respiratory effort) measured with the Sunrise mandibular jaw movement (MJM) home sleep monitoring device, from 1 month before to 6 months after orthognathic surgery (bilateral sagittal split osteotomy with or without Le Fort I osteotomy). Twenty-five patients aged 15 years or older, scheduled for orthognathic surgery as part of standard care at CHR Sambre et Meuse (Namur, Belgium) and screened positive for sleep-disordered breathing risk, will be included. Results will be used to generate hypotheses and to size a future confirmatory study.
Detailed description
Design: prospective, exploratory, single-center, non-randomized cohort without control group. Surgery is indicated and performed as part of standard care and is not assigned by the protocol; the study adds standardized measurements before and after surgery. Screening and inclusion (two steps): (1) STOP-BANG score >= 3 and/or high risk on the Berlin questionnaire; (2) only if step 1 is positive, a first Sunrise night at 1 month before surgery (T-1 month), considered positive if AHI >= 5 events/h OR REMOV >= 15% of total sleep time. Both steps must be positive for inclusion. The 15% REMOV threshold is an operational screening threshold chosen for this study and is not a validated cut-off. Schedule: T-1 month: virtual surgical planning (IPS CaseDesigner) from intraoral scans, facial multidetector CT in natural head position, clinical parameters, two consecutive Sunrise nights and questionnaires (STOP-BANG, Berlin, ESS, FSS, FOSQ-10, SF-12, EQ-5D-5L). Day 0: bilateral sagittal split osteotomy with or without Le Fort I osteotomy, mandible-first sequence, single surgeon. Postoperative visits at 1 week and 4 weeks. T+6 months: facial CT in natural head position, postoperative virtual analysis, two consecutive Sunrise nights and the same questionnaires. Sample size: 25 participants, based on pilot study recommendations (Sim \& Lewis; Whitehead et al.). Assuming a mean AHI change of about 5 events/h and a standard deviation of 7 events/h, 25 patients provide a 95% confidence interval of approximately +/- 3 events/h around the mean change. Analysis: descriptive and exploratory; paired comparisons between T-1 month and T+6 months; exploratory association between surgical movements and changes in AHI/REMOV. Data are collected on paper source documents and a pseudonymized Excel database at the study site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthognathic surgery cohort | – | Procedure: Orthognathic surgery (BSSO with or without Le Fort I osteotomy), Device: Sunrise mandibular jaw movement monitoring, Diagnostic Test: Facial multidetector CT in natural head positionPatients aged 15 years or older scheduled for bilateral sagittal split osteotomy with or without Le Fort I osteotomy as part of standard care, with positive two-step screening for sleep-disordered breathing risk. Sunrise monitoring (2 nights) and facial CT are performed 1 month before and 6 months after surgery. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients aged 15 years or older referred to the maxillofacial surgery department of CHR Sambre et Meuse, Meuse site (Namur, Belgium), and scheduled for orthognathic surgery after orthodontic-surgical multidisciplinary assessment.
Key inclusion criteria (4 listed)
- Dentoskeletal deformity requiring bilateral sagittal split osteotomy with or without Le Fort I osteotomy after orthodontic-maxillofacial multidisciplinary assessment.
- Age 15 years or older at consent, with completed skeletal growth according to department practice.
- Positive two-step screening for sleep-disordered breathing risk: (1) STOP-BANG score >= 3 and/or high risk on the Berlin questionnaire; and (2) on the first Sunrise night at 1 month before surgery, AHI >= 5 events/h or REMOV >= 15% of total sleep time.
- Signed informed consent (co-signed by holders of parental authority for minors). - Ability to use the Sunrise device at home.
Key exclusion criteria (7 listed)
- Medical or anesthetic contraindication to orthognathic surgery.
- Known severe sleep-disordered breathing (AHI >= 30/h) treated preoperatively with CPAP or a mandibular advancement device.
- Syndromic craniofacial malformation (e.g., Crouzon syndrome, Pierre Robin sequence).
- Known allergy or skin intolerance to the Sunrise sensor materials or adhesive, or active dermatosis of the submental area.
- Current pregnancy or breastfeeding.
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 |
|---|---|---|
| Orthognathic surgery (BSSO with or without Le Fort I osteotomy)Standard-of-care orthognathic surgery under general anesthesia, mandible-first sequence, planned with 3D virtual surgical planning (IPS CaseDesigner, KLS Martin) and in-house printed splints. Not assigned by the study protocol. | Procedure or surgery | Orthognathic surgery cohort |
| Sunrise mandibular jaw movement monitoringChin-mounted MJM sensor (Sunrise, Namur, Belgium) used at home for two consecutive nights before surgery and two consecutive nights 6 months after surgery to derive respiratory and sleep indices. | Device | Orthognathic surgery cohort |
| Facial multidetector CT in natural head positionFacial CT at 1 month before and 6 months after surgery for 3D upper airway volume analysis; field restricted to the facial skeleton, dose optimized. | Diagnostic test | Orthognathic surgery cohort |
Primary outcome
Change in apnea-hypopnea index (AHI) measured by mandibular jaw movement monitoring
Time frame: From 1 month before surgery (baseline) to 6 months after surgery
AHI (events/h) measured with the Sunrise device; absolute change (T+6 months minus T-1 month) and relative change (%). Only absolute change is reported if baseline AHI < 1 event/h.
Change in respiratory effort burden (REMOV)
Time frame: From 1 month before surgery (baseline) to 6 months after surgery
Percentage of total sleep time with increased respiratory effort (REMOV, %TST) measured with the Sunrise device; absolute change (percentage points) and relative change (%). Only absolute change is reported if baseline REMOV < 5% TST.
11 secondary outcomes
Change in Oxygen Desaturation Index (ODI)
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Respiratory Effort-Related Arousal (RERA) Index
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Sleep Onset Latency
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Wake After Sleep Onset (WASO)
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Change in Sleep Fragmentation Index
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Change in STOP-BANG Questionnaire Score
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Percentage of Participants Classified as High Risk on the Berlin Questionnaire
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Mandibular Advancement and Change in AHI
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Maxillary Advancement and Change in AHI
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Mandibular Advancement and Change in REMOV
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Correlation Between Maxillary Advancement and Change in REMOV
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
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 3 Nov 2026.
- Results publication: PubMed 26606321Zaghi S, Holty JE, Certal V, Abdullatif J, Guilleminault C, Powell NB, Riley RW, Camacho M. Maxillomandibular Advancement for Treatment of Obstructive Sleep Apnea: A Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2016 Jan;142(1):58-66. doi: 10.1001/jamaoto.2015.2678.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study team, in accordance with the informed consent and the EU General Data Protection Regulation. Aggregated results will be published.
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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.
jerome decaux, MD principal investigator
CHR Sambre et Meuse - Site Meuse, Avenue Albert Ier 185, Namur, 5000, Belgium
1 site 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 and Sleep Apnea, Obstructive, run by CHR Sambre et Meuse Site Meuse 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 7 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 3 Nov 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?
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 Jerome Decaux, MD (0032474523674, jerome.decaux@chrsm.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in apnea-hypopnea index (AHI) measured by mandibular jaw movement monitoring (time frame: From 1 month before surgery (baseline) to 6 months after surgery). The study lists 2 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 NCT07910461, 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 3 Nov 2026.