Trial · NCT07910461
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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. |
| Secondary | Correlation Between Maxillary Advancement and Change in AHI | From 1 month before surgery (baseline) to 6 months after surgery. | 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. |
| Secondary | Correlation Between Mandibular Advancement and Change in REMOV | 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 percentage of total sleep time with increased respiratory effort (REMOV, %) measured by the Sunrise system between baseline and 6 months. |
| Secondary | Correlation Between Maxillary Advancement and Change in REMOV | From 1 month before surgery (baseline) to 6 months after surgery. | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07910461/registered