The Efficacy of a Titrated Tongue Stabilizing Device on Obstructive Sleep Apnea and the Quality of Life: A Clinical Trial Study Protocol
Bibliographic record
Abstract
JDSMStudy Objectives: To establish the safety and efficacy of a novel oral appliance (O2Vent Mono, Oventus Medical Pty Ltd., Brisbane, Australia), that incorporates a built-in enclosed airway, as an alternative treatment for obstructive sleep apnea (OSA).Methods: A prospective, single-arm, single-center study was performed.Participants had mild-moderate OSA or continuous positive airway pressure (CPAP) intolerant severe OSA.Ambulatory polysomnography (PSG), subjective snoring, and subjective nasal obstruction were assessed at baseline and following acclimatization with the device.Baseline mandibular protrusion was set at 50% and was increased to a maximum of 85% if required as determined by questionnaire and PSG.Participants with a ≥ 50% reduction in apnea-hypopnea index (AHI) were classified as responders.Compliance was recorded via a questionnaire.Results: In 29 participants (20 males, 9 females), mean ± standard deviation age = 49.3 ± 8.6 years, body mass index = 29.9 ± 6.1 kg/m 2 , AHI decreased from 41.8 ± 26.5 to 16.2 ± 15.4 (P < .001) or 62.5 ± 21.1%.Time spent below 90% oxygen saturation as assessed by pulse oximetry improved from 9.3 ± 12.7% to 2.2 ± 3.4% (P = .001).Seventeen participants (59%) had subjective nasal obstruction and 22 (75.9%) were classified as responders.Subgroup analysis between those with nasal obstruction (NO) and without nasal obstruction (NNO) revealed no significant difference in percentage of change in AHI from baseline (NO = 66.3 ± 18.1%, NNO = 57.0 ± 24.6%, P = .280)or response rate (NO = 76.5%,NNO = 75%, chi-square = 0.930).Overall compliance was 82.8%, and three minor transient device-related adverse events occurred.Conclusions: This novel device was safe, effective, and well tolerated in a group of participants with relatively severe OSA.There was a clinically and statistically significant reduction in AHI of 62% as well as improvement in oxygen saturation.Importantly, the efficacy and response do not appear to be reduced by the presence of nasal obstruction. Clinical Trial Registration:Trial name: A prospective, single arm, single center pilot trial to establish the safety and efficacy of the Oventus device to treat mild to moderate obstructive sleep apnea and snoring.URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367532.
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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 | 0.046 | 0.054 |
| Meta-epidemiology (narrow) | 0.005 | 0.003 |
| Meta-epidemiology (broad) | 0.008 | 0.006 |
| Bibliometrics | 0.003 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.008 | 0.008 |
| Insufficient payload (model declined to judge) | 0.049 | 0.011 |
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".