Three-year Efficacy of Proximal and Distal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea Was Comparable in the THN3 and STAR Trials
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Le résumé fourni par la source
Abstract RATIONALE: Phase III trials of proximal and distal hypoglossal nerve stimulation (pHGNS and dHGNS) for obstructive sleep apnea (OSA), THN3 and STAR, respectively, enrolled disparate cohorts that received different versions of HGNS. Nonetheless, previously reported one-year outcome statistics were remarkably similar. Detailed, longer-term comparisons have heretofore not been available. METHODS: Probability density functions (PDFs), which comprehensively describe variability across subjects, were derived for Apnea-Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), Epworth Sleepiness Scale (ESS), and Functional Outcomes of Sleep Questionnaire (FOSQ) at Baseline, as well as for changes from Baseline at visits Month 12-36. Metalog regression using raw data or summary statistics, as available, was used to produce highly accurate PDFs (with adjusted R2∼1). THN3 and STAR PDFs were compared with the overlap coefficient (OVL) of shared area. Baseline Body Mass Index (BMI) was also compared with summary statistics. RESULTS: At Baseline, differences were observed in BMI (THN3: 29.8±3.0, STAR: 28.4±2.6 kg/m2, Mean±SD) as well as PDFs (Figure) of AHI (OVL=72%) and ODI (OVL=63%) but not ESS (OVL=94%) and FOSQ (OVL=92%). Baseline differences in BMI, AHI, and ODI were consistent with different trial eligibility criteria: THN3 limited BMI at ≤35 kg/m2 versus ≤32 kg/m2 in STAR, while STAR excluded participants with concentric collapse on sleep endoscopy and THN3 did not. During follow-up, changes in AHI, ODI, ESS and FOSQ were generally comparable (with OVL≥85%, see Figure). PDFs further revealed details not evident from conventionally-reported summary statistics: (1) despite moderate to severe OSA in THN3 and STAR cohorts, wide ranges of values were observed for ESS and FOSQ at Baseline, including substantial proportions in the normal range, and (2) PDFs of changes from Baseline for all outcomes exposed variation in treatment responses to both pHGNS and dHGNS, indicating that the mean response in both trials did not accurately estimate the most probable treatment outcome. For example, the maximum PDF value (mode statistic) for AHI reduction from Baseline at 36 Months was 25.3 and 20.6 for THN3 and STAR, whereas the mean responses were 12.5 and 18.8 for THN3 and STAR, respectively. CONCLUSIONS: pHGNS and dHNGS have comparable long-term efficacy in sleep-disordered breathing, oxygenation, and patient-reported outcomes over 3 years despite different eligibility criteria, baseline characteristics, and treatment approaches between THN3 and STAR trials. Evidence points to a broad spectrum of responses in both trials not intuitively apparent from descriptive statistics.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Three-year Efficacy of Proximal and Distal Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea Was Comparable in the THN3 and STAR Trials
- Date Crossref
- 01/05/2025
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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Vanderbilt University pays non établi dans la noticeUniversité ou école supérieure
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University of Pennsylvania pays non établi dans la noticeUniversité ou école supérieure
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ENT and Allergy pays non établi dans la noticeÉtablissement de santé
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Vanderbilt University, University of Pennsylvania et ENT and Allergy, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.