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Observational Study
. 2025 Feb 28;29(1):115.
doi: 10.1007/s11325-025-03263-w.

Optimizing treatment of the novel intra-oral negative pressure for obstructive sleep apnea

Hua-Yu Lin #  1 , Chun-Tung Nien #  2 , Chia-Chi Chen  1   2 , Il-Ing Hong  3 , Chen Lin  4 , Chia-Mo Lin  5   6
Affiliations
Observational Study

Optimizing treatment of the novel intra-oral negative pressure for obstructive sleep apnea

Hua-Yu Lin et al. Sleep Breath. .

Abstract

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.

Keywords: Intra-oral negative pressure therapy (OPT); Sleep-disordered breathing; Titration; Upper airway physiology.

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Conflict of interest statement

Declarations. Ethical approval: All procedures performed in studies involving human participants were in accordance with the ethical standards of Shin Kong Wu Ho-Su Memorial Hospital and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent: Informed consent was obtained from all individual participants included in the study. Conflict of interest: All authors certify that they have no affiliations with or involvement in any organization or entity with any financial interest, or non-financial interest in the subject matter or materials discussed in this manuscript.

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