0506 5-year, multi-center, observational study to assess safety, effectiveness and use of CAD/CAM patient-matched OAT for OSA treatment
Bibliographic record
Abstract
Abstract Introduction Oral appliance therapy (OAT) is used for the treatment of obstructive sleep apnea in mild to moderate patients. First-time fit is important for treatment burden and dental economics. This prospective, “real-world” collaborative (physician/dentist) study will assess the primary endpoint of at least a 50% reduction in baseline apnea-hypopnea index (AHI) at five years. Additionally, this study will assess fit during initial delivery. The Panthera D-SAD is a CAD/CAM, 3D-printed OAT. Updated design and comfort features have been integrated. Changeable rods (mechanical hinge) provide the mechanism for protrusion. This study fulfills French reimbursement requirements. Methods OAT naïve individuals with moderate OSA (AHI 15-30) or those with severe OSA (AHI 30 or greater) who decline CPAP will be included, meeting all other criteria. An estimated 337 participants will be enrolled at 11 centers in France. Consecutive sampling will be used. Participants will be medically assessed, a prescription for OAT obtained, dental assessment and then, the initial fitting will be at Visit 1 (V1). Standard of care for the study duration will be followed. Evaluation time points are three months (medical), six months (dental), two years (both), and five years (both). Secondary endpoints include OAT side effects, oxygen desaturation indices, quality of life, self-reported adherence, and subjective symptoms at the aforementioned time points Results To date, a total of 56 subjects have been enrolled. This report is focused on the 24 subjects who have had V1, OAT fit, and titration visits. The demographics are as follows:(F=8); Averages (and standard deviation) for the following are age 51.2 (1.5).; baseline AHI of 20.5 (6.07); ODI 14.71(8.9); SpO2 93.46 (1.06), BMI 25.73 (3.13), and rod length of 26.6mm (1.05). 91.6% of dentists reported at V1 that no rod changes were required. 82.6% of patients indicated the OAT was comfortable, three patients had dental or muscle pain, and one, the device was too tight. Conclusion V1 is a crucial step in the therapeutic journey. This early data demonstrate a high OAT acceptance rate for dentists and patients while reducing the time required for first-time fit, thus lowering practitioner and patient burden and costs. Support (if any) Panthera Dental Inc, Quebec City, Quebec Canada
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".