Department of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium.
Thorax. 2013 Jan;68(1):91-6. doi: 10.1136/thoraxjnl-2012-201900. Epub 2012 Sep 19.
Oral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report.
In this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0 ± 11.9/h; age 47 ± 10 y; BMI 26.6 ± 4.0 kg/m(2); men/women: 31/20). Patients were unaware of the purpose of the study.
No microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6 ± 1.3 h per day with a regular OA users' rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%.
The results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.
口腔矫治器（OA）治疗作为睡眠呼吸障碍（SDB）的非持续气道正压通气治疗方法，应用日益广泛。尽管 OA 治疗对 SDB 的疗效已有报道，但关于依从性的数据仅限于自我报告。
在这项为期 3 个月的前瞻性临床试验中，主要结果是评估在 51 例确诊为 SDB 的连续患者（AHI18.0±11.9/h；年龄 47±10 岁；BMI26.6±4.0kg/m2；男/女：31/20）中使用嵌入式微传感器温度计对 OA 治疗中的依从性进行客观测量的安全性和可行性，该微传感器温度计带有片上集成读出电子设备。患者不知道研究的目的。
未记录到与微传感器相关的不良事件。此外，在读取依从性数据时也没有遇到问题。在 51 个微传感器中，有一个出现技术缺陷，失访。在这项研究中，OA 使用的整体客观平均率为 6.6±1.3h/d，3 个月随访时的常规 OA 使用者率为 82%。统计分析显示，在这项研究中，客观和自我报告的 OA 依从性数据之间没有显著差异。OA 依从性的客观测量使我们能够计算客观依从性和治疗效果的乘积，即平均疾病缓解（MDA）。MDA 作为整体治疗效果的衡量标准，结果为 51.1%。
结果表明 OA 依从性的客观测量是安全且可行的。OA 依从性的客观测量可以计算 MDA。
