Introduction:
The objective of this study was to demonstrate how the intraoral Negative Air Pressure (iNAP®), a novel medical device which retains tongue and soft palate during sleep for adults with snoring and obstructive sleep apnea (OSA).
Material & Methods:
This was an open-label, prospective, non-comparative, single-center study designed to evaluate the efficacy of the intraoral negative air pressure device through fiberoptic nasopharyngoscopy with Müller's maneuver (FNMM), cephalometric and polysomnography (PSG). For standardization, the FNMM was performed by the same physician by standard Müller's maneuver procedure from nasal cavity to the lower oropharynx. The nasopharyngoscopy was anchored at the level cephalad to the Passavant’s ridge. Meanwhile, the cephalometric was all taken by the same technologist with eyes and ears of patients set at 80 degrees in supine position and analyzed by the same radiologist. The PSG was performed and analyzed following the 2007 American Academy of Sleep Medicine (AASM) recommended rules, where hypopnea was required to have at least a 30% airflow reduction and a 4% SaO2 desaturation.
Results:
Thirty-seven (37) evaluable patients with body-mass index (BMI) at 26.41 ± 4.16 kg/m2 and age at 41.15 ± 11.71 years were analyzed. The baseline apnea-hypopnea index (AHI) were ranged from 1.90 to 107.90. With treatment intervention, the AHI median statistically significantly decreased by 8.50 (13.90, 0.40); a total of 32.43% of patients’ treated AHI was lower than 20 and reduced more than 50%.
As proven clinically effective by the PSG, we also investigated the correlations of the AHI change rate and the upper airway structure with or without the device via FNMM and cephalometric. The AHI change rate and the pharynx space change was statically proven through X-ray film (p/value: 0.035). The retroglossal space was also significantly released under FNMM (p/value: 0.029). The ability of the intraoral negative air pressure device to stabilize the soft tissues in the oral cavity and releasing spaces for the upper airway was even clearly shown in the patients whose treated AHI below 20 and reduction more than 50%. The retropalatal spaces were also significantly released by the intraoral negative air pressure device under FNMM (p/value: 0.003). As the nasopharynx surrounded by the bony structure, the mechanism of the intraoral negative air pressure device addressing on the tongue in the oral cavity leading to the pharynx space releasing from the retropalatal and retroglossal but not nasopharynx was demonstrated.
Conclusion:
The mechanism of the intraoral negative air pressure device, iNAP® sleep therapy system, in treating OSA was through stabilizing the tongue and the soft palate leading to the patency of the upper airway by forming negative pressure within the confined oral cavity was established.
Key Words:
Apnea, hypopnea index, obstructive sleep apnea, intraoral negative air pressure, therapy
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