Introduction: Beyond CPAP—A Needed Shift in Sleep Therapy  

Obstructive Sleep Apnea (OSA) affects nearly one billion individuals worldwide, yet millions remain undiagnosed or undertreated. As clinical guidelines prioritize Continuous Positive Airway Pressure (CPAP) as first-line therapy, a significant challenge persists in real-world adherence. Between 43% and 86% of patients report difficulty tolerating CPAP due to discomfort, claustrophobia, noise, and reduced sleep quality. These limitations can compromise outcomes, especially in patients with comorbid cardiovascular or neurocognitive disorders. 

The iNAP device, a mask-free intraoral negative pressure system, offers a new path forward, particularly for CPAP-intolerant patients seeking a more lifestyle-compatible solution. This article equips healthcare providers with essential insights into the iNAP system’s mechanism, evidence, patient selection, and clinical integration strategy.  

What Is the iNAP Device?  

The iNAP system introduces a novel therapeutic class: oral negative pressure therapy (OPT). Unlike CPAP, which splints the airway open using continuous air, iNAP creates gentle suction inside the mouth to reposition oral structures and stabilize the airway without air flow, tubing, or external masks.  

Components include:  

• A soft, custom-molded oral interface 
• A portable vacuum console (battery-operated) 
• A tubing system and saliva reservoir  

Once activated, the system generates and maintains a consistent negative air pressure (–20 to –30 cmH₂O) in the oral cavity during sleep. This gently pulls the soft palate forward and positions the tongue base anteriorly, reducing the likelihood of airway collapse and promoting uninterrupted nasal breathing.  

Mechanism of Action: Stabilizing the Airway via Suction  

The iNAP device delivers therapeutic benefit through a biomechanical mechanism that does not depend on airflow. The intraoral vacuum it creates results in:  

• Anterior traction on the soft palate and tongue base 
• Expansion of the retropalatal and retroglossal spaces 
• Stabilization of upper airway structures throughout the respiratory cycle  

By eliminating the need for mask pressure or airflow delivery, iNAP minimizes treatment-related discomfort, avoids upper airway drying, and reduces arousals triggered by airflow noise or leaks. The device promotes physiologic breathing and preserves natural sleep architecture—two factors often disrupted by traditional CPAP therapy.  

Clinical Evidence: What the Data Shows  

An accumulating body of peer-reviewed literature supports the safety and efficacy of iNAP in appropriately selected patient populations.  

1. Real-world studies  

In a 2019 prospective study, Hung et al. evaluated iNAP in 35 adults with OSA1. After a 1-week usage period, 64% of patients demonstrated improvement in AHI, with responders more likely to have mild to moderate OSA and non-obese BMI profiles. Subjective satisfaction with the device was high, and no significant adverse effects were reported.  

Yamaguchi et al. followed a cohort of moderate OSA patients aged 45–652. Key outcomes included reduced average AHI from 22.2 to 15.6 and improved Epworth Sleepiness Scale (ESS) scores from 14.0 to 9.1. These findings reinforce the device's impact on respiratory events, daytime alertness, and quality of life.  

2. Meta-analytic support  

Camacho et al. conducted a meta-analysis of 140 patients receiving oral pressure therapy (iNAP or equivalent) for sleep apnea3. Results showed a pooled reduction in AHI of 42.6% (from 37.18 to 21.35 events/hour). Patients with mild/moderate OSA and positional apnea responded best, confirming that individualized therapy matching is key to optimizing outcomes.  

3. Use during sleep endoscopy  

Drug-Induced Sleep Endoscopy (DISE) studies have confirmed the mechanical effect of iNAP on upper airway structures. Kuo et al. reported a 40.2% improvement in velar obstruction and a 51% response when iNAP was combined with head rotation4. These imaging findings offer strong physiologic validation for the device’s mechanism.  

Patient Selection: Who Benefits Most?  

Like any targeted therapy, success with iNAP depends on choosing the right patient phenotype. Clinicians should evaluate both anatomic and behavioral factors before recommending the device.  

Best-suited candidates:  

• Adults with mild to moderate OSA (AHI 5–30) 
• Patients who are non-adherent or intolerant to CPAP 
• Individuals with tongue base or soft palate collapse 
• Patients with normal nasal patency (nasal breathing is essential) 
• Travelers or patients needing compact, battery-powered therapy  

Caution or exclusion in:  

• Severe nasal congestion, deviated septum, or untreated rhinitis 
• Central sleep apnea or neuromuscular respiratory disorders 
• Individuals with significant dental instability or recent oral surgery 
• Patients with xerostomia or saliva management issues  

A home trial combined with watchful, objective monitoring is often the most reliable way to assess responsiveness.  

Practical Benefits: What Patients Report  

Unlike CPAP, which affects multiple sensory modalities (facial contact, airflow pressure, auditory disturbance), iNAP’s design optimizes discretion, comfort, and lifestyle adaptability.  

Reported patient benefits include:  

• No facial straps, no airflow-related noise 
• Freedom to change sleeping position or sip water 
• Compatibility with speech and partner interaction during usage 
• High portability for travel or remote environments 
• Minimal maintenance requirements—no filters or humidifiers  

Early adopter clinics report that iNAP improves patient satisfaction, particularly among previously non-adherent CPAP users.  

How Does iNAP Compare to Other Modalities?  

Device Cost and Reimbursement Considerations  

The iNAP device price typically ranges with pricing determined by distribution models, provider markup, and country-specific health coverage schemes. Some sleep clinics offer rental options, subscription plans, or trial-to-purchase programs to reduce upfront cost barriers.  

Reimbursement pointers:  

• FDA-cleared and CE-marked, supporting regulatory legitimacy 
• Often eligible for out-of-network coverage if CPAP intolerance is documented 
• CPT code eligibility may vary; check payer policies locally 
• May be bundled into broader OSA management pathways (e.g., sleep coaching + diagnostics)  

Ultimately, cost conversations should focus on long-term adherence, lifestyle compatibility, and the cost of untreated OSA (e.g., cardiometabolic risk, workplace accidents).  

Integrating iNAP into Clinical Workflow  

To maximize adoption and patient success, clinics can integrate iNAP into structured sleep care protocols:  

1. Initial Evaluation 

• Screen CPAP non-adherent patients 
• Confirm OSA diagnosis via PSG or HSAT 
• Use DISE or imaging (if available) to identify favorable anatomy 

2. Education & Expectations 

• Discuss how iNAP differs from CPAP or MADs 
• Use a demo unit to introduce fit and function 
• Reinforce trial nature and the need for follow-up 

3. Home Trial & Monitoring 

• Offer 1–2-week trial with monitoring (e.g., WatchPAT™, HSAT) 
• Collect symptom logs, ESS scores, and partner feedback 

4. Treatment Continuation or Titration 

• Select best-fit patients based on AHI improvement and tolerability 
• Offer additional support (video guides, technician check-ins) 
• Schedule regular reassessments and encourage adherence to documentation 

5. Multidisciplinary Touchpoints 

• Coordinate with dental sleep providers, pulmonologists, and ENT teams 
• Add iNAP to the therapeutic ladder for personalized treatment planning  

Final Thoughts: The Value Proposition for HCPs  

The iNAP system represents a meaningful advancement in sleep apnea personalization. For healthcare professionals, it opens the door to:  

• Broadening therapeutic offerings beyond CPAP 
• Improving patient satisfaction and retention 
• Aligning treatment with real-world patient behavior and needs 
• Expanding clinic services to include adherence-first alternatives  

As clinical practice shifts toward shared decision-making and value-based care, devices like iNAP will become increasingly relevant, not just as alternatives to CPAP but as frontline solutions for patients prioritizing comfort.  

Call to Action  

If your patients struggle with CPAP adherence or are seeking a more comfortable sleep apnea solution, consider the iNAP device. Visit <Taevas website> for detailed information or call <Taevas contact number>  to request a hands-on demonstration. Discover how iNAP’s mask-free design can enhance patient satisfaction and improve treatment compliance today.  

REFERENCES  

1. Hung TC, Liu TJ, Hsieh WY, et al. A novel intermittent negative air pressure device ameliorates obstructive sleep apnea syndrome in adults. Sleep Breath. 2019;23(3):849-856. doi:10.1007/s11325-018-01778-z 
2. Yamaguchi Y. The Effect of Intermittent Negative Air Pressure, iNAP® on Subjective Daytime Sleepiness in Middle-aged Patients with Moderate Obstructive Sleep Apnea. J Sleep Disord Ther. 2020;9(5):318. doi:10.35248/2167-0277.20.9.318. 
3. Camacho M, Song SA, Tolisano AM. Oral pressure therapy (winx) for obstructive sleep apnea: a meta-analysis updating the systematic review. Sleep Breath. 2016;20(3):1011-1012. doi:10.1007/s11325-016-1350-z. 
4. Kuo YH, Liu TJ, Chiu FH, et al. Novel Intraoral Negative Airway Pressure in Drug-Induced Sleep Endoscopy with Target-Controlled Infusion [published correction appears in Nat Sci Sleep. 2022 Jan 27;14:135-136. doi: 10.2147/NSS.S358965.]. Nat Sci Sleep. 2021;13:2087-2099. Published 2021 Nov 24. doi:10.2147/NSS.S327770.