{"title":"新型口腔负压治疗阻塞性睡眠呼吸暂停的优化治疗。","authors":"Hua-Yu Lin, Chun-Tung Nien, Chia-Chi Chen, Il-Ing Hong, Chen Lin, Chia-Mo Lin","doi":"10.1007/s11325-025-03263-w","DOIUrl":null,"url":null,"abstract":"<p><strong>Study objectives: </strong>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.</p><p><strong>Methods: </strong>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<sup>®</sup> 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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial registration: </strong>Registry: ClinicalTrials.gov; Name: Real-World Experiences of the iNAP<sup>®</sup> Lite in OSA Adults in Taiwan; Identifier: NCT03559322.</p>","PeriodicalId":21862,"journal":{"name":"Sleep and Breathing","volume":"29 1","pages":"115"},"PeriodicalIF":2.0000,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Optimizing treatment of the novel intra-oral negative pressure for obstructive sleep apnea.\",\"authors\":\"Hua-Yu Lin, Chun-Tung Nien, Chia-Chi Chen, Il-Ing Hong, Chen Lin, Chia-Mo Lin\",\"doi\":\"10.1007/s11325-025-03263-w\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Study objectives: </strong>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.</p><p><strong>Methods: </strong>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<sup>®</sup> 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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>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.</p><p><strong>Clinical trial registration: </strong>Registry: ClinicalTrials.gov; Name: Real-World Experiences of the iNAP<sup>®</sup> Lite in OSA Adults in Taiwan; Identifier: NCT03559322.</p>\",\"PeriodicalId\":21862,\"journal\":{\"name\":\"Sleep and Breathing\",\"volume\":\"29 1\",\"pages\":\"115\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2025-02-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Sleep and Breathing\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s11325-025-03263-w\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Sleep and Breathing","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11325-025-03263-w","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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.
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.