Trial · NCT07910461
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
NCT07910461, Not yet recruiting, CHR Sambre et Meuse Site Meuse
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO). Trials, record NCT07910461. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910461
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
- NCT number
- NCT07910461
- Status
- Not yet recruiting
- Enrollment
- 25 participants, estimated
- Lead sponsor
- CHR Sambre et Meuse Site Meuse
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, Obstructive, Dentofacial Deformities
- Interventions
- Orthognathic surgery (BSSO with or without Le Fort I osteotomy), Sunrise mandibular jaw movement monitoring, Facial multidetector CT in natural head position
- First posted
- 2026-11-02
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in apnea-hypopnea index (AHI) measured by mandibular jaw movement monitoring | 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. |
| Primary | Change in respiratory effort burden (REMOV) | 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. |
| Secondary | Change in Oxygen Desaturation Index (ODI) | From 1 month before surgery (baseline) to 6 months after surgery. | 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). |
| Secondary | Change in Respiratory Effort-Related Arousal (RERA) Index | From 1 month before surgery (baseline) to 6 months after surgery. | 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. |
| Secondary | Change in Sleep Onset Latency | From 1 month before surgery (baseline) to 6 months after surgery. | Time from lights-off to sleep onset (minutes), measured by the Sunrise system. Not a scale score; higher values indicate worse sleep initiation. |
| Secondary | Change in Wake After Sleep Onset (WASO) | From 1 month before surgery (baseline) to 6 months after surgery. | Total time awake after sleep onset (minutes), measured by the Sunrise system. Not a scale score; higher values indicate worse sleep continuity. |
| Secondary | Change in Sleep Fragmentation Index | From 1 month before surgery (baseline) to 6 months after surgery. | 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). |
| Secondary | Change in STOP-BANG Questionnaire Score | From 1 month before surgery (baseline) to 6 months after surgery. | 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). |
| Secondary | Percentage of Participants Classified as High Risk on the Berlin Questionnaire | From 1 month before surgery (baseline) to 6 months after surgery. | 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. |
| Secondary | Correlation Between Mandibular Advancement and Change in AHI | From 1 month before surgery (baseline) to 6 months after surgery. | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26606321 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910461
GET https://conductscience.org/api/trials/v1/NCT07910461/registered