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Feasibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation

Award Number: R43HL147788
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2020
PERIOD OF PERFORMANCE END DATE: 03/31/2022

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Feasibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation - 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 patient'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. Axon'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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2023 ( Subtotal = -$5,483 )
2023	2020	AXON MEDICAL INC	3478 WEST 2100 SOUTH #300	SALT LAKE CITY	UT	84119	SALT LAKE	USA	Lung Diseases Research	000	1	11/1/2022	NEW	-$5,483
														Subtotal = -$5,483

Issue Date FY: 2020 ( Subtotal = $224,225 )
2020	2020	AXON MEDICAL INC	3478 WEST 2100 SOUTH #300	SALT LAKE CITY	UT	84119	SALT LAKE	USA	Lung Diseases Research	000	1	6/18/2020	NEW	$224,225
														Subtotal = $224,225

Grand Total All Awards = $218,742

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Feasibility Testing of a Microphone System to Facilitate Patient Communication During Noninvasive Ventilation

Award Number: R43HL147788

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2020

PERIOD OF PERFORMANCE END DATE: 03/31/2022

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