An observational study in Obstructive Sleep Apnea, Sleep Apnea, Obstructive and Dentofacial Deformities, sponsored by CHR Sambre et Meuse Site Meuse. Not yet recruiting at 1 site in Belgium. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by CHR Sambre et Meuse Site Meuse · Observational
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.
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.
2,271 studies on the registry are indexed under Sleep Apnea, Obstructive; 472 are open to participants now.
This study's planned enrollment of 25 is below the median of 103 across 671 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →This is the only study on the registry with CHR Sambre et Meuse Site Meuse as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Nov 3, 2026. See what changed
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
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.
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 CT at 1 month before and 6 months after surgery for 3D upper airway volume analysis; field restricted to the facial skeleton, dose optimized.
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.
Time frame: 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.
Time frame: From 1 month before surgery (baseline) to 6 months after surgery
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From 1 month before surgery (baseline) to 6 months after surgery.
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.
Of 259 non-industry observational studies under Sleep Apnea, Obstructive, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 60. This study's planned 7 months is below that.
Counting every sponsor, half of 294 studies reached it within 30 months; a quarter within 15 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.