比较两种下颌前移矫治器治疗中度阻塞性睡眠呼吸暂停的随机对照交叉试验。
A randomised controlled crossover trial comparing two mandibular repositioning appliances for treatment of moderate obstructive sleep apnoea.
文献信息
| PMID | 42955526 |
|---|---|
| 原文 | 在 PubMed 查看原文 ↗ |
| 发表日期 | 2026 |
| 作者 | Jorden Blok |
| 作者单位 | Oral and Maxillofacial Surgery department, Ziekenhuis Oost-Limburg (ZOL), Genk, 3600, Belgium. jordenblok@hotmail.com. |
| 期刊 | Sleep & breathing = Schlaf & Atmung |
| SCI 分区 | Q3 |
| IF | 2.8 |
| 研究类型 | 临床研究 · 临床 |
| 所属专科 | 咽喉科 |
中文摘要
目的： 比较两种定制的双块下颌前移矫治器 SomnoDent® Flex 与 OrthoApnea NOA® 在中度阻塞性睡眠呼吸暂停（OSA）成人中的效果。
方法： 单中心（比利时亨克）随机两周期、两序列交叉试验。经多导睡眠监测证实 AHI 5-30 次/小时的成人符合条件；所有入组者均为中度 OSA（AHI 15.1-29.7）。参与者按 1:1 随机分配至 SomnoDent® Flex-NOA® 或相反顺序，每种矫治器佩戴三个月，洗脱期两周。参与者和临床医生未设盲；结局评分者对矫治器设盲。注册的主要结局为每种矫治器相对基线的 AHI 变化。矫治器间治疗后 AHI 差异在一项非预设的主要比较分析中评估，使用线性混合效应模型，以矫治器、周期和序列为固定效应。
结果： 16 名参与者被随机分组，每个序列 8 名，均纳入分析。中位 AHI 从基线 17.6 次/小时降至 SomnoDent® Flex 的 3.1 次/小时和 NOA® 的 2.3 次/小时（两者相对基线 p < 0.001）。矫治器间差异为 +0.16 次/小时（95% CI -2.56 至 +2.87；p = 0.904），存在周期效应（第 2 周期 +3.82 次/小时，与从家庭便携监测改为实验室多导睡眠监测同时发生；p = 0.009）。未发现次要结局有显著差异；事后分析中，AHI < 5 次/小时在 SomnoDent® Flex 组达到 12/16，在 NOA® 组达到 10/16。无参与者因不良事件退出；不良事件未被系统记录。
结论： 两种矫治器均与 AHI 降低相关。非预设的矫治器间比较未检测到统计学显著差异，且不能确立等效性。周期与测量方法之间的完全混杂，加之依从性、滴定和不良事件数据不足，限制了对两种矫治器总体比较优点的结论。
试验注册： ClinicalTrials.gov NCT06810479，于 2025 年 2 月 5 日注册，在首次入组之前。
英文摘要
PURPOSE: To compare two custom-made bi-block mandibular repositioning appliances, the SomnoDent® Flex and the OrthoApnea NOA®, in adults with moderate obstructive sleep apnoea (OSA).
METHODS: Randomised two-period, two-sequence crossover trial at a single centre (Genk, Belgium). Adults with polysomnography-confirmed AHI 5-30 events/h were eligible; all enrolled had moderate OSA (AHI 15.1-29.7). Participants were randomised 1:1 to SomnoDent® Flex-NOA® or the reverse sequence, each worn for three months with a two-week washout. Participants and clinicians were unblinded; outcome scorers were blinded to appliance. The registered primary outcome was the change in AHI from baseline for each appliance. The between-appliance difference in post-treatment AHI was assessed in a non-prespecified principal comparative analysis using linear mixed-effects models with appliance, period and sequence as fixed effects.
RESULTS: Sixteen participants were randomised, eight per sequence, and all were analysed. Median AHI fell from 17.6 events/h at baseline to 3.1 with the SomnoDent® Flex and 2.3 with the NOA® (both p < 0.001 versus baseline). The between-appliance difference was + 0.16 events/h (95% CI - 2.56 to + 2.87; p = 0.904), with a period effect (+ 3.82 events/h in period 2, coinciding with the change from home polygraphy to in-laboratory polysomnography; p = 0.009). No secondary outcome differed significantly; post hoc, AHI < 5 events/h was reached in 12/16 (SomnoDent® Flex) and 10/16 (NOA®). No participant discontinued for an adverse event; adverse events were not systematically recorded.
CONCLUSION: Both appliances were associated with reductions in AHI. The non-prespecified between-appliance comparison detected no statistically significant difference and does not establish equivalence. Complete confounding between period and measurement methodology, together with insufficient adherence, titration and adverse-event data, limits conclusions about the overall comparative merits of the appliances.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06810479, registered 5 February 2025, prior to first enrolment.