| 摘要: | 引言
阻塞性睡眠呼吸暫停症（OSA）是一種常見且嚴重的睡眠障礙，特徵是在睡眠期間上呼吸道反覆塌陷，導致呼吸中止或顯著減少。OSA的高發病率及其潛在的嚴重併發症，如心血管疾病、高血壓、代謝紊亂和神經精神疾病，使得尋找有效的治療方法變得至關重要。
研究背景與目的
傳統的OSA治療方法主要包括持續正壓呼吸器（CPAP）、口內裝置（Oral Appliance）和手術等。然而，這些方法存在一定的局限性，如CPAP治療的耐受性問題，口內裝置對部分患者的有效性不足，以及手術的侵入性和風險 。本研究旨在評估口內負壓裝置（iNAP）在治療OSA患者中的效果和安全性，並探索其作為OSA替代治療方案的潛力。
MRI研究方法
所有MRI影像均使用3.0 Tesla掃描器，採用32通道頭部線圈進行掃描。採用二維單鏡頭渦輪場回波進行區域分析和三維體積計算，以減少吞咽運動偽影 。受試者在MRI檢查過程中裝置了MRI相容的EEG電極和鼻氣流監測導管，確保受試者正確使用iNAP。
療效研究方法
療效研究是一項前瞻性、自我對照、盲性樞紐試驗，涉及32名OSA患者，其中包括28名男性和4名女性，平均年齡為47.4歲，平均體重指數（BMI）為26.59 kg/m² 。研究使用多導睡眠監測（PSG）技術記錄受試者的睡眠狀況，並在治療前後比較主要終點變數，包括呼吸暫停低通氣指數（AHI）、血氧飽和度（SpO2）和睡眠結構參數。
研究結果
MRI影像分析
MRI影像顯示，使用iNAP裝置後，上呼吸道的整體容積和顎後及舌後區域的最大面積和體積均顯著增加。尤其在清醒和睡眠狀態下，這些變化尤為明顯。根據基線特性數據，治療反應組（Responder）和無反應組（Non-responder）在使用iNAP前後的變化均有顯著差異。
PSG數據分析
研究結果顯示，iNAP裝置顯著降低了OSA患者的AHI，從基線值32.04次/小時降至治療後的8.79次/小時。此外，患者的最低SpO2從80.0%提高到85.5%。PSG數據顯示，iNAP治療顯著改善了患者的睡眠結構，增加了N3階段（深睡眠）百分比，減少了覺醒指數。
結論
iNAP裝置是一種安全且有效的OSA治療選擇，能顯著改善患者的AHI、SpO2和睡眠結構。治療結果顯示，使用iNAP裝置後，總睡眠時間、睡眠效率、N1階段和N2階段的百分比沒有顯著變化，但N3階段、REM階段和覺醒指數顯著改善。這表明iNAP裝置能夠有效改善睡眠呼吸暫停，特別是在深睡眠和快速眼動睡眠階段的質量上。研究表明，iNAP裝置作為一種非侵入性的OSA治療方法，具有顯著的療效和良好的安全性，為OSA患者提供了一種有效的替代治療選擇 。
未來研究方向
研究建議未來應進行更多的隨機對照試驗，以進一步驗證iNAP裝置的治療效果。還建議探索iNAP與其他治療方法的結合使用，例如牙套和CPAP，以提供更多樣化的治療選擇  。此外，增加樣本量和延長研究時間，可以更全面地了解iNAP在不同OSA患者群體中的長期效果和耐受性。
;Introduction
Obstructive Sleep Apnea (OSA) is a common and severe sleep disorder characterized by repeated collapse of the upper airway during sleep, leading to cessation or significant reduction in breathing. The high prevalence of OSA and its potential severe complications, such as cardiovascular diseases, hypertension, metabolic disorders, and neuropsychiatric illnesses, underscore the critical need for effective treatment modalities.
Research Background and Objectives
Traditional OSA treatment methods include Continuous Positive Airway Pressure (CPAP), oral appliances, and surgery. However, these methods have limitations such as tolerance issues with CPAP, insufficient effectiveness of oral appliances for some patients, and the invasiveness and risks associated with surgery. This study aims to evaluate the effectiveness and safety of intraoral negative pressure devices (iNAP) in treating OSA patients and to explore their potential as an alternative treatment option.
MRI Study Methods
All MRI images were acquired using a 3.0 Tesla scanner with a 32-channel head coil. Two-dimensional single-shot turbo spin-echo imaging for regional analysis and three-dimensional volumetric calculations were utilized to minimize swallowing artifacts. During the MRI examinations, participants were equipped with MRI-compatible EEG electrodes and nasal airflow monitoring tubes to ensure proper use of iNAP.
Efficacy Study Methods
The efficacy study was a prospective, self-controlled, blind pivotal trial involving 32 OSA patients, including 28 males and 4 females, with an average age of 47.4 years and a mean Body Mass Index (BMI) of 26.59 kg/m². The study employed polysomnography (PSG) to record participants’ sleep conditions and compared primary endpoint variables before and after treatment, including the Apnea-Hypopnea Index (AHI), oxygen saturation (SpO2), and sleep architecture parameters.
Study Results
MRI Imaging Analysis
MRI imaging revealed significant increases in overall upper airway volume and the maximum area and volume in the retroglossal and retropharyngeal regions after using the iNAP device. These changes were particularly notable during both wakefulness and sleep states. According to baseline characteristics, significant differences were observed between the responder and non-responder groups before and after using iNAP.
PSG Data Analysis
The results indicated that the iNAP device significantly reduced AHI in OSA patients, from a baseline of 32.04 events/hour to 8.79 events/hour post-treatment. Furthermore, the minimum SpO2 improved from 80.0% to 85.5%. PSG data demonstrated that iNAP treatment significantly enhanced sleep architecture, increasing the percentage of N3 stage (deep sleep) and reducing the arousal index.
Conclusion
The iNAP device is a safe and effective treatment option for OSA, significantly improving AHI, SpO2, and sleep structure. Treatment outcomes showed that while total sleep time, sleep efficiency, and the percentages of N1 and N2 stages did not change significantly, there were significant improvements in the N3 stage, REM stage, and arousal index. This indicates that the iNAP device effectively improves sleep apnea, particularly the quality of deep and rapid eye movement sleep stages. The study demonstrates that iNAP, as a non-invasive treatment method for OSA, offers significant therapeutic efficacy and safety, providing an effective alternative treatment option for OSA patients.
Discussion
The study suggests further randomized controlled trials to validate the therapeutic effects of the iNAP device. It is also recommended to explore the combination use of iNAP with other treatment modalities such as dental appliances and CPAP to provide more diverse treatment options. Additionally, increasing the sample size and extending study durations would enable a more comprehensive understanding of the long-term effects and tolerability of iNAP across different OSA patient groups. |
