Objective

To evaluate the use of direct to consumer Prefabricated adjustable thermoplastic mandibular advancement devices (PAT-MADs) (MyTAP™, Airway Management Inc), its effectiveness in the treatment of OSA, feasibility and short-term adherence.

Methods

In sum, 50 patients with diagnosed mild-moderate OSA on formal polysomnography (PSG) were fitted with a PAT-MAD (MyTAP™, Airway Management Inc). Sleep indices included the apnea–hypopnea index (AHI), hypopnea index (HI), apnea index (AI); oxygen desaturation index (ODI), and the lowest 0₂ saturation (Lsat) were measured with a Level 3 home sleep apnea test (HSAT) pre versus post treatment. Quality of life (QOL) surveys of Epworth sleepiness scale (ESS), Pittsburg sleep quality index (PSQI), Functional outcomes of sleep quality-10 (FOSQ10) and satisfaction surveys were administered.

Results

Over three months, indices showed a trend towards improvement. Results were statistically significant when stratified into groups who achieved cure and success. Moreover, there was a mean improvement in AHI: −12.7 ± 9.3, AI: −5.7 ± 8.2, HI: −6.3 ± 3.7, ODI: −11.2 ± 8.6 for responders with a success rate of 41%. Out of QOL surveys, ESS showed a decrease of −1.41 [−2.52, −0.3] (p = 0.017) when controlled for age and body mass index (BMI). Up to 68.8% of patients found that the device was useful in alleviating snore symptoms. Adherence rate was reported at 59%.

Conclusion

Titratable PAT-MAD is an economical and effective option for a patient of Chinese descent. It has the potential to serve as a device for trial use and means of selection before proceeding with customized MADs. Further studies will be required to substantiate other factors which influence the recommendation of MADs for patients with this demographic.

中文翻译：

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预制可调节热塑性下颌前移装置（PAT-MADs）用于阻塞性睡眠呼吸暂停的评估：亚洲经验。

目的

评估直接面向消费者的预制可调节热塑性下颌前移装置（PAT-MAD）（MyTAP™，Airway Management Inc）的使用，其在OSA治疗中的有效性，可行性和短期坚持性。

方法

总而言之，对50例经正规多导睡眠图（PSG）诊断为轻度中度OSA的患者安装了PAT-MAD（MyTAP™，Airway Management Inc）。睡眠指数包括呼吸暂停-呼吸不足指数（AHI），呼吸不足指数（HI），呼吸暂停指数（AI）；氧饱和度指数（ODI）和最低0 ₂饱和度（Lsat）在治疗前和治疗后分别通过3级家庭睡眠呼吸暂停测试（HSAT）进行了测量。进行了Epworth嗜睡量表（ESS），匹兹堡睡眠质量指数（PSQI），睡眠质量10的功能结局（FOSQ10）的生活质量（QOL）调查和满意度调查。

结果

在过去的三个月中，指数呈改善趋势。将结果分为治愈和成功组时，结果具有统计学意义。此外，对于应答者，AHI平均改善：-12.7±9.3，AI：-5.7±8.2，HI：-6.3±3.7，ODI：-11.2±8.6，成功率为41％。在QOL调查中，如果控制年龄和体重指数（BMI），则ESS下降-1.41 [-2.52，-0.3]（p = 0.017）。高达68.8％的患者发现该设备可缓解打sn症状。依从性报告为59％。

结论

Titratable PAT-MAD对华裔患者是一种经济有效的选择。在进行定制的MAD之前，它有可能用作试用设备和选择手段。将需要进一步的研究来证实影响该人群患者推荐MAD的其他因素。