Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Minimally Invasive, Battery-less, Closed-loop Hypoglossal Nerve Stimulator for Treatment of Obstructive Sleep Apnea

Award Number: R61HL179737
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2028

Group Awards By:

View Award Description

Minimally Invasive, Battery-less, Closed-loop Hypoglossal Nerve Stimulator for Treatment of Obstructive Sleep Apnea - The primary goal of this proposal is to develop a wirelessly powered, battery-free hypoglossal nerve stimulator (HNS) designed to treat obstructive sleep apnea (OSA). This new device aims to provide a minimally invasive solution that includes bilateral stimulation and integrated electromyography (EMG) sensing for closed-loop control, addressing the limitations of existing HNS systems. Background: Obstructive sleep apnea (OSA) is a prevalent disorder characterized by repeated interruptions in breathing during sleep, significantly increasing the risk of cardiovascular diseases and other health conditions. Continuous Positive Airway Pressure (CPAP) therapy is commonly used but has a high non-compliance rate. The current FDA-approved HNS device (Inspire Therapy System) requires complex and invasive surgery involving an implanted battery and long leads, which also limits MRI compatibility. Nyxoah’s wirelessly powered device, although noteworthy, also has significant issues such as electrode migration and the need for precise placement of an external wearable. Innovation: The proposed HNS device will overcome these limitations through several innovations. It will be wirelessly powered, eliminating the need for an implanted battery. The device will be miniaturized to reduce surgical complexity and improve MRI compatibility. EMG sensors will be integrated into the implant to provide real-time muscle response measurements, enabling closed-loop control of the stimulation. Additionally, small tines on the leads will reduce migration risk, and a peel-away delivery tool will minimize invasiveness. Specific Aims: Aim 1: Develop a wirelessly powered, battery-free HNS device with closed-loop control. The first aim focuses on designing and building the HNS implant, integrating EMG sensors for real-time monitoring, and developing closed-loop algorithms to optimize stimulation parameters. This will leverage technology from previous work supported by an NHLBI grant. Aim 2: Test the performance and ease of implantation in an acute porcine model. This aim involves assessing the wireless power transfer, EMG signal quality, and overall performance of the device under various conditions. The implantation procedure will be evaluated using a peel-away delivery tool, and the physical movement of the tongue and muscle response will be measured in response to varying stimulation parameters. Aim 3: Evaluate the biosafety and regulatory readiness in a chronic porcine model. The final aim will involve biocompatibility, hemocompatibility, and histopathology testing over a period of up to 6 months. Additionally, a comprehensive regulatory strategy will be developed, including an FDA pre-submission to streamline the approval process for future clinical applications.


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: 2026 ( Subtotal = $257,015 )
2026	2026	VIVAMED, INC.	124 IDAHO AVE UNIT 404	SANTA MONICA	CA	90403	LOS ANGELES	USA	National Center on Sleep Disorders Research	000	1	6/19/2026	NEW	$257,015
														Subtotal = $257,015

Grand Total All Awards = $257,015

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Minimally Invasive, Battery-less, Closed-loop Hypoglossal Nerve Stimulator for Treatment of Obstructive Sleep Apnea

Award Number: R61HL179737

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/15/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer