| dc.description.abstract | 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. | en_US |