Effect of lemborexant on sleep parameters and architecture in adult and elderly participants with mild-to-severe obstructive sleep apnea
Bibliographic record
Abstract
OBJECTIVE: To evaluate sleep parameters and architecture in a post hoc analysis of participants with untreated obstructive sleep apnea (OSA) who received lemborexant (LEM) 10 mg (LEM10), a competitive dual orexin-receptor antagonist approved for the treatment of adults with insomnia. METHODS: Study E2006-A001-102 (Study 102; NCT03471871) and Study E2006-A001-113 (Study 113; NCT04647383) were multicenter, randomized, double-blind, placebo (PBO)-controlled, 2-period cross-over studies in participants with mild OSA (apnea-hypopnea index [AHI] ≥5 to <15 events/hour) and moderate (AHI ≥15 to <30 events/hour) or severe OSA (AHI ≥30 events/hour), respectively. Participants were randomized to 1 of 2 treatment sequences (Sequence A: PBO/LEM10; Sequence B: LEM10/PBO) consisting of 8 nights of treatment (LEM10 or PBO), with each treatment period separated by a ≥14-day washout period. Sleep onset, maintenance, and architecture data were assessed on Day 1 and Day 8 with polysomnography. Safety data were collected. RESULTS: In total, 39 patients with mild OSA and 33 patients with moderate or severe OSA were included. Total sleep time and sleep efficiency were significantly higher (improved) following single and multiple doses of LEM10 regardless of OSA severity. Following single and multiple doses of LEM10, wake after sleep onset was significantly lower (improved) and total non-rapid eye movement (REM) sleep and REM sleep duration were longer versus PBO. LEM10 was generally well tolerated. CONCLUSIONS: These results, in combination with previously reported respiratory safety data, suggest that LEM may be an insomnia treatment option for patients with untreated OSA. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (identifier: NCT03471871); ClinicalTrials.gov (identifier: NCT04647383).
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".