Axon Medical Inc — Department of Health and Human Services SBIR Phase I: NHLBI

Description

PROJECT SUMMARY/ABSTRACT This Phase 1 SBIR proposal focuses on improving communication between clinicians and patients undergoing noninvasive ventilation (NIV) for acute respiratory failure. Noninvasive ventilation in hospital settings is life- saving and highly effective, but it requires use of a mask that covers the nose and mouth obstructing speech. This mask severely limits patient communication. Because of this lack of communication, patients often report feeling they are unable to speak up about their care needs, suffer high levels of anxiety, and may suffer more delirium. An innovative NIV accessory (the ReddyPort Oral Access Elbow) has introduced access into the NIV mask utilizing a large one-way valve. Using this FDA-approved valve, a microphone can be placed into the mask to allow a patient to freely communicate using their voice without interrupting NIV. In this grant, we propose the improvement and testing of a voice amplification system consisting of a microphone module that is placed into the mask through the ReddyPort Oral Access Elbow and that connects to a bedside speaker that amplifies the voice. We plan to improve systems for voice intelligibility including improving the microphone module, introducing a breathing noise cancellation system, and designing a system for naturalizing the patientandapos;s voice. We will then test this system on both volunteers and patients to further iterate the device and perfect the systems for improving speech intelligibility. In a subsequent Phase II, the device will be tested in a clinical trial powered for efficacy endpoints including anxiety, engagement, and delirium. Axonandapos;s team has demonstrated commercial success with several devices and looks forward to bringing this device through regulatory approvals to commercialization in order to reduce patient anxiety and improve engagement during the life-threatening illness of acute respiratory failure.PROJECT NARRATIVE Patients undergoing non-invasive ventilation (NIV) often experience debilitating anxiety that can often lead to failure of the therapy and poor health outcomes. This anxiety has been strongly linked to an inability to communicate freely (due to traditional NIV mask design) leading to a loss of a feeling of control. We propose a robust voice amplification system for patients undergoing NIV that will restore the patientandapos;s capacity to speak without interrupting life-saving NIV, thereby improving patient-centered outcomes.