Efficacy and safety of fire needle therapy for obstructive sleep apnea-hypopnea syndrome: study protocol for a single arm clinical trial
Bibliographic record
Abstract
Abstract Background Obstructive sleep apnea hypopnea syndrome (OSAHS) is a sleep disorder characterized by repeated apnea and hypopnea while you're asleep, and the prevalence rate increases annually. Previous research revealed that the fire needle therapy for OSAHS good clinical efficacy but lacked proof from clinical trials. Therefore, we designed this single-arm clinical trial protocol to investigate the effectiveness and safety of treating OSAHS using fire needle therapy. Methods/design: 166 adult subjects with mild to moderate OSAHS, ranging in age from 18 to 70, will be included in this study. All subjects will receive fire needle therapy twice a week for 4 weeks and follow-up for 12 months. The following points will include outcome assessment: (1) baseline;(2) 4 weeks following treatment's start;(3) 3 months following treatment's start; (4) 12 months following treatment's start. The primary outcome of the trial is the AHI index, and the secondary outcomes include oxygen desaturation index(ODI), lowest nocturnal oxygen saturation (LSpO2), percentage of SaO2 < 90% in total sleep time (TS90%), apnea index (AI), hypopnea index (HI), subjective symptoms (by ESS score, TCM syndrome score). Safety assessments include vital sign monitoring, routine blood tests, routine urine tests, blood biochemistry, the skin Reaction Scale, the modified Vancouver scar score, and adverse events. Discussion This single-arm clinical registry study will provide evidence-based medical evidence for the efficacy and safety of fire needle therapy in OSAHS. Trail registration: Chinese Clinical Trial Registry, ChiCTR2100042309. Registered on January 7, 2021.
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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 | 0.022 | 0.022 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.003 |
| Scholarly communication | 0.004 | 0.003 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.007 | 0.007 |
| Insufficient payload (model declined to judge) | 0.046 | 0.010 |
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".