UH Study of Inhalation Pressure Relief Device for CPAP Published in Journal of Clinical Sleep Medicine

Innovations in Pulmonology, Critical Care & Sleep Medicine | Summer 2025

Pulmonary and sleep specialists at University Hospitals Cleveland Medical Center recently completed a laboratory bench study of V-Com™, an innovative inspiratory pressure release (IPR) device designed to lower inspiratory pressures while preserving the benefits of continuous positive airway pressure (CPAP) and maintaining expiratory positive airway pressure (EPAP) levels.

Ambrose Chiang, MD

The researchers published their findings in the Journal of Clinical Sleep Medicine.

“Improving CPAP adherence is a significant concern in sleep medicine,” says Ambrose Chiang, MD, a senior staff physician within the UH Division of Pulmonary, Critical Care, and Sleep Medicine and a clinical associate professor at Case Western Reserve University School of Medicine. “Although CPAP is highly effective for obstructive sleep apnea, many patients fail to tolerate CPAP or utilize their device adequately.”

Despite various innovations — such as auto-CPAP, bilevel PAP and expiratory pressure profile modification that aimed to improve comfort and tolerance — none have significantly enhanced long-term CPAP adherence.

Dr. Chiang partnered with Kingman Strohl, MD, and Susheel Patil, MD, PhD, to independently assess V-Com’s efficacy. In collaboration with the Cleveland Clinic Simulation and Advanced Skills Center, the team connected the ResMed AirSense 11 CPAP machine to the IngMar Medical’s ASL-5000 breathing simulator to measure the impact of V-Com on inspiratory and expiratory pressures at normal lung settings.

“Our objective was to conduct a rigorous evaluation of inspiratory and expiratory pressure dynamics in a controlled laboratory environment using a sophisticated breathing simulator,” Dr. Chiang says. “This will help us understand what to expect in various clinical scenarios from this innovative CPAP accessory and how we can use it appropriately.”

Key findings from this laboratory bench study demonstrated that:

• Integration of a single IPR unit led to a statistically significant reduction in mean inspiratory pressure, with marginal decrements in mean expiratory pressure.
• Higher CPAP settings resulted in more pronounced reductions in both inspiratory and expiratory pressure.
• Across all fixed CPAP settings, inspiratory pressure reduction consistently exceeded expiratory pressure decrements.

Considerations in Other More Complex Scenarios

Historically, optimizing EPAP settings has taken precedence over an emphasis on addressing inspiratory pressure. “Expiratory pressure profile modification, such as expiratory pressure release [EPR] and C-Flex, has long been a standard feature on CPAP machines,” Dr. Chiang says. “While these features can make exhalation a bit easier, their use has not resulted in clinically significant differences in CPAP adherence.”

“V-Com has a simple design and worked well as expected in normal lung model settings at CPAP pressure under 12-14 cm H2O,” Dr. Chiang says. “However, patients receiving higher CPAP settings or multiple IPR units in series may necessitate pressure compensation to ensure therapeutic efficacy.”

Additionally, Dr. Chiang advises against concurrent IPR and EPR deployment, a scenario that can easily arise in contemporary clinical settings, as this combination can cause significant reductions in end-expiratory pressure required for improved airway patency and stability.

V-Com is registered by the U.S. Food and Drug Administration as a CPAP accessory, requiring no prescription. While durable medical equipment vendors can add it to the CPAP circuitry without a physician’s input, Dr. Chiang recommends that sleep medicine clinicians carefully oversee the clinical application of the device to ensure appropriate use for each patient, whether during CPAP titration in the sleep lab or home use.

Next Steps

The research team is planning further testing of V-Com utilizing diverse CPAP brands, bilevel PAP and auto-CPAP under simulated sleep apnea conditions, and will eventually test the emerging Kairos-PAP (KPAP) device. Further investigations are warranted in those with severe chronic obstructive pulmonary disease and other hypoventilation disorders, who may require higher IPR than EPR and, hence, may not be ideal V-Com candidates.

“We plan to extend our investigation to different lung disease models,” Dr. Chiang says. “Ultimately, the implementation of independent randomized clinical trials will be crucial for evaluating critical parameters such as patient comfort, CPAP adherence and clinical outcomes while simultaneously identifying optimal target populations for this novel therapeutic intervention.”

For more information, contact Dr. Chiang at Ambrose.Chiang@UHhospitals.org.

Contributing Expert:
Ambrose Chiang, MD
Senior staff physician
Division of Pulmonary, Critical Care and Sleep Medicine
University Hospitals Cleveland Medical Center
Clinical Associate Professor
Case Western Reserve University School of Medicine
Division of Sleep Medicine
Louis Stokes Cleveland VA Medical Center