两种可调节下颌前伸装置对阻塞性睡眠呼吸暂停患者呼吸参数和上呼吸道尺寸影响的比较：一项随机对照试验。
Comparisons of the effects of two types of titratable mandibular advancement devices on respiratory parameters and upper airway dimensions in patients with obstructive sleep apnea: a randomized controlled trial.
机构信息
Department of Orofacial Pain and Dysfunction, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.
Department of Oral Radiology, Academic Centre for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, 1081 LA, the Netherlands.
出版信息
Clin Oral Investig. 2023 May;27(5):2013-2025. doi: 10.1007/s00784-023-04945-z. Epub 2023 Mar 17.
OBJECTIVES
To compare the effects of two types of titratable mandibular advancement devices (MADs), namely MAD-H (allowing limited vertical opening) and MAD-S (allowing free vertical opening), on respiratory parameters and upper airway dimensions in patients with mild to moderate obstructive sleep apnea (OSA).
MATERIALS AND METHODS
Patients with mild to moderate OSA (5 ≤ apnea-hypopnea index (AHI) < 30 /h) were randomly assigned to two parallel MAD groups. All MADs were subjectively titrated according to a standardized protocol during a 3-month follow-up. Every patient underwent two polysomnographic recordings, and two cone beam computed tomography scans in supine position: one at baseline and another one after 3 months with the MAD in situ. The primary outcome variables were the AHI in supine position (AHI-supine) and the minimal cross-sectional area of the upper airway in supine position (CSAmin-supine).
RESULTS
A total of 49 patients were recruited, and 31 patients (21 men and 10 women) with a mean (± SD) age of 48.5 (± 13.9) years and a mean AHI of 16.6 (± 6.7) /h completed the study. In the per-protocol analysis, there was no significant difference between MAD-H (n = 16) and MAD-S (n = 15) in their effects on AHI-supine (P = 0.14) and CSAmin-supine (P = 0.59). Similar results were found in the intention-to-treat analysis (P = 0.47 and 0.57, respectively).
CONCLUSIONS
Within the limitations of this study, we conclude that there is no significant difference in the effects of an MAD allowing limited vertical opening and an MAD allowing free vertical opening on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA.
CLINICAL RELEVANCE
MADs allowing limited vertical opening and allowing free vertical opening have similar effects on respiratory parameters and upper airway dimensions in patients with mild to moderate OSA.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02724865. https://clinicaltrials.gov/ct2/show/NCT02724865.
目的
比较两种可调节下颌前伸装置（MAD）的效果，即 MAD-H（允许有限的垂直开口）和 MAD-S（允许自由的垂直开口），在轻度至中度阻塞性睡眠呼吸暂停（OSA）患者的呼吸参数和上气道尺寸方面的作用。
材料和方法
将轻度至中度 OSA（5≤呼吸暂停低通气指数（AHI）<30 / h）的患者随机分配到两个平行的 MAD 组。所有 MAD 根据 3 个月的随访期间的标准化方案进行主观滴定。每位患者接受两次多导睡眠图记录和两次仰卧位锥形束计算机断层扫描：一次在基线时，另一次在使用 MAD 后的 3 个月时。主要观察变量是仰卧位 AHI（AHI-supine）和仰卧位上气道最小横截面积（CSAmin-supine）。
结果
共招募了 49 名患者，其中 31 名患者（21 名男性和 10 名女性）完成了研究，平均年龄（±标准差）为 48.5（±13.9）岁，平均 AHI 为 16.6（±6.7）/ h。在符合方案分析中，MAD-H（n=16）和 MAD-S（n=15）在仰卧位 AHI（P=0.14）和 CSAmin-supine（P=0.59）方面的效果无显著差异。意向治疗分析也得到了类似的结果（分别为 P=0.47 和 0.57）。
结论
在本研究的限制范围内，我们得出结论，在轻度至中度 OSA 患者中，允许有限垂直开口的 MAD 和允许自由垂直开口的 MAD 在呼吸参数和上气道尺寸方面的效果无显著差异。
临床相关性
允许有限垂直开口和允许自由垂直开口的 MAD 在轻度至中度 OSA 患者的呼吸参数和上气道尺寸方面具有相似的效果。
试验注册
ClinicalTrials.gov 标识符：NCT02724865。https://clinicaltrials.gov/ct2/show/NCT02724865。
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