新型口腔负压治疗阻塞性睡眠呼吸暂停的优化治疗。

IF 2 4区 医学 Q3 CLINICAL NEUROLOGY
Hua-Yu Lin, Chun-Tung Nien, Chia-Chi Chen, Il-Ing Hong, Chen Lin, Chia-Mo Lin
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引用次数: 0

摘要

研究目的:阻塞性呼吸暂停的口腔负压治疗(OPT)向口腔内输送负压以增加上气道通畅,已被证明是一种有效的CPAP替代治疗方法。而不是一刀切的压力,认为需要个体化的负压滴定,以达到最佳的治疗效果。本研究旨在评估压力滴定过程后的OPT结果。方法:共30例OSA患者(3例女性,基线AHI 39.59±20.05事件/h)完成OPT滴定PSG研究。在OPT滴定研究中,OPT设备(iNAP®Lite, Somnics inc.)的压力从-40 mmHg开始。当满足以下条件之一时,≧2次阻塞性呼吸暂停,≧3次低呼吸暂停,≧5次低呼吸暂停,≧3分钟大鼾声,至少增加- 10mmhg。每次压力调整的效果在下一次调整前至少观察15分钟。当处理压力达到- 250mmhg时,停止滴定过程。结果:83%的受试者达到了成功的治疗标准(AHI)。结论:本研究中,随着给定负压的增加,OSA患者的呼吸暂停和低呼吸次数减少。结果表明,增加口内负压可进一步提高OPT治疗睡眠呼吸暂停的效果和疗效。临床试验注册:注册:ClinicalTrials.gov;名称:iNAP®生活在台湾OSA成人中的真实体验;标识符:NCT03559322。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Optimizing treatment of the novel intra-oral negative pressure for obstructive sleep apnea.

Study objectives: Intra-oral negative pressure therapy (OPT) for obstructive apnea delivers a negative pressure into the oral cavity to increase the upper airway patency and has been shown as an effective CPAP alternative treatment. Rather than one-size-fits-all pressure, it is believed that individualized titration of the negative pressure is needed to achieve the optimal treatment effectiveness. This study aims to evaluate the outcome of OPT after the pressure titration process.

Methods: A total of 30 people with OSA (3 females, with baseline AHI 39.59 ± 20.05 events/h) completed the OPT titration PSG study. In the OPT titration study, the pressure of the OPT device (iNAP® Lite, Somnics inc.) started at -40 mmHg. The negative pressure increases at least - 10 mmHg if one or more of the following conditions were met (1) ≧ Two obstruction apnea, (2) ≧ 3 hypopneas, (3) ≧ 5 RERAs, (4) ≧ 3 min of loud snoring. The effect of each pressure adjustment is observed for at least 15 min before the next adjustment. The titration process is stopped if the treatment pressure reaches - 250 mmHg.

Results: The result indicates that 83% of subjects achieve the successful treatment criteria (AHI < 5) under individuals' optimal treatment pressure. The mean AHI reduced by 80% with iNAP treatment compared to baseline (8.17 ± 8.123 vs. 9.59 ± 20.05 events/hr). In addition, the percentage of NREM stage 3 (14.89 ± 10.69 vs. 23.23 ± 12.10) and arousal index (48.47 ± 23.78 vs. 26.23 ± 11.43) were significantly improved after treatment compared to baseline. The effectiveness of the OPT significantly increased after the pressure lower than - 100 mmHg compared to the baseline pressure (66.67% vs. 26.67%; p = 0.0042).

Conclusions: In this study, the number of apnea and hypopnea decrease in the OSA patients as increases in the given negative pressure. That result shows that increasing intraoral negative pressure would further improve the treatment effectiveness and efficacy of OPT for sleep apnea.

Clinical trial registration: Registry: ClinicalTrials.gov; Name: Real-World Experiences of the iNAP® Lite in OSA Adults in Taiwan; Identifier: NCT03559322.

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来源期刊
Sleep and Breathing
Sleep and Breathing 医学-呼吸系统
CiteScore
5.20
自引率
4.00%
发文量
222
审稿时长
3-8 weeks
期刊介绍: The journal Sleep and Breathing aims to reflect the state of the art in the international science and practice of sleep medicine. The journal is based on the recognition that management of sleep disorders requires a multi-disciplinary approach and diverse perspectives. The initial focus of Sleep and Breathing is on timely and original studies that collect, intervene, or otherwise inform all clinicians and scientists in medicine, dentistry and oral surgery, otolaryngology, and epidemiology on the management of the upper airway during sleep. Furthermore, Sleep and Breathing endeavors to bring readers cutting edge information about all evolving aspects of common sleep disorders or disruptions, such as insomnia and shift work. The journal includes not only patient studies, but also studies that emphasize the principles of physiology and pathophysiology or illustrate potentially novel approaches to diagnosis and treatment. In addition, the journal features articles that describe patient-oriented and cost-benefit health outcomes research. Thus, with peer review by an international Editorial Board and prompt English-language publication, Sleep and Breathing provides rapid dissemination of clinical and clinically related scientific information. But it also does more: it is dedicated to making the most important developments in sleep disordered breathing easily accessible to clinicians who are treating sleep apnea by presenting well-chosen, well-written, and highly organized information that is useful for patient care.
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