New Study Shows Adjustable Intraoral Negative Pressure Therapy Significantly Improves Treatment Outcomes for Obstructive Sleep Apnea

Background

Obstructive Sleep Apnea (OSA) is a common sleep-related breathing disorder with a high prevalence among adults worldwide. Beyond impairing sleep quality, OSA has been shown to be strongly associated with increased risks of cardiovascular and metabolic diseases.

Continuous Positive Airway Pressure (CPAP) therapy remains one of the standard treatment options for OSA. However, discomfort and poor long-term adherence often limit its clinical effectiveness, prompting continued exploration of alternative therapies with higher patient acceptance.

Recently, a new study published in the international journal Sleep and Breathing compared fixed-pressure intraoral negative pressure therapy with adjustable-pressure intraoral negative pressure therapy in patients with OSA. The results demonstrated that adjustable-pressure therapy provided significantly improved treatment outcomes.

This study also serves as a key clinical investigation supporting U.S. FDA clearance for intraoral negative pressure therapy. Designed as a multinational, multicenter clinical trial conducted across medical institutions in the United States and Europe, the study systematically evaluated the efficacy and safety of adjustable-pressure therapy in patients with moderate to severe OSA.

Study Results

A total of 30 patients with obstructive sleep apnea were enrolled. Using a stepwise pressure titration protocol, individualized therapeutic pressure settings were determined for each participant. The multicenter design included leading clinical institutions in the United States and Germany, ensuring both data diversity and clinical applicability.

Under optimal therapeutic pressure, 83% of patients achieved treatment success (AHI < 5), representing a significant improvement compared to fixed-pressure therapy. In addition, the mean Apnea-Hypopnea Index (AHI) was reduced by approximately 80% from baseline. Sleep architecture and micro-arousal indices also showed marked improvement.

Clinical Significance and Value

Patient Benefits

Through individualized pressure titration, adjustable intraoral negative pressure therapy provides a more precise and flexible treatment approach. Compared with fixed-pressure therapy, it effectively reduces apnea and hypopnea events, improves sleep quality, decreases daytime sleepiness, and enhances overall quality of life.

Clinical Value for Physicians

For clinicians, adjustable intraoral negative pressure therapy offers an evidence-based alternative treatment option, particularly for patients who demonstrate poor adherence or suboptimal response to CPAP therapy. The simplified titration process facilitates rapid identification of optimal therapeutic pressure, improving treatment efficiency and success rates.

Implications for Therapy Development

By addressing the limitations of fixed-pressure intraoral negative pressure therapy, the adjustable pressure technology evaluated in this study significantly enhances therapeutic efficacy through optimized pressure parameters. This clinical trial strengthens the evidence base for the therapy and supports its standardized adoption in clinical practice.

Journal Background and Impact

Sleep and Breathing is a well-established international journal in the field of sleep medicine, dedicated to publishing original research on sleep-related breathing physiology, disorders, and treatments. Studies published in the journal frequently inform clinical decision-making and guide future research directions.

The publication of this study further expands the clinical evidence supporting intraoral negative pressure therapy in OSA treatment and provides a solid foundation for future clinical applications.

Conclusion

The findings of this study demonstrate that adjustable intraoral negative pressure therapy offers significant clinical advantages in the treatment of obstructive sleep apnea. Through individualized pressure titration, the therapy improves treatment response rates and overall efficacy, providing an evidence-supported therapeutic option for patients with OSA.

At the same time, the study offers clinicians practical clinical guidance and contributes to the broader adoption of intraoral negative pressure therapy in real-world healthcare settings.

References

Lin, H.-Y., Nien, C.-T., Chen, C.-C., Hong, I.-I., Lin, C., & Lin, C.-M.

Intra-oral Negative Pressure Therapy (iNAP) for Obstructive Sleep Apnea: Outcome after Pressure Titration.

Sleep and Breathing, 2025.

DOI: 10.1007/s11325-025-03263-w