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Recognizing and resolving laterally directed pharyngeal collapse for successful hypoglossal nerve stimulation therapy in OSA

Award Number: R01HL180582
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/03/2026
PERIOD OF PERFORMANCE END DATE: 06/30/2031

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Recognizing and resolving laterally directed pharyngeal collapse for successful hypoglossal nerve stimulation therapy in OSA - PROJECT SUMMARY/ABSTRACT Obstructive Sleep Apnea (OSA) is a common and debilitating disorder characterized by the collapse of one or more pharyngeal structures during sleep (velum, oropharyngeal lateral walls, tongue base, and/or epiglottis). First line treatment for OSA is continuous positive airway pressure (CPAP), but half of patients fail this treatment. An emerging alternative to CPAP called hypoglossal nerve stimulation (HGNS) involves electrical activation of the genioglossus muscle to protrude the tongue anteriorly and open the airway. However, the therapy remains limited by a mandatory invasive screening procedure, known as drug-induced sleep endoscopy (DISE), in two ways: 1) it limits patient access by using surgeon time and operating room resources, and 2) the screening criterion determined from a small study (n=21)—presence of complete concentric collapse of the soft palate (CCC)—does not accurately characterize the anatomical cause of cause of HGNS failure. The present study proposes laterally directed pharyngeal collapse as the anatomical cause of HGNS failure. To demonstrate this, we will show that resolving lateral collapse can reverse this mechanism of HGNS failure. In addition, we propose a method to non-invasively identify patients with lateral collapse who are likely to fail HGNS and are thus candidates for treatment of lateral collapse. In Aim 1, we will study 100 patients undergoing HGNS implantation and demonstrate that both forms of severe lateral collapse—complete concentric collapse (CCC) and oropharyngeal lateral wall (OPLW) collapse—are associated with reduced HGNS efficacy due to impaired HGNS-induced improvement in airway collapsibility. ● In Aim 2, we will test whether the role of lateral collapse in HGNS failure is reversible (i.e., causal) by administering an intervention to attenuate lateral collapse (LCi, i.e., tonsillectomy) and improve HGNS efficacy. This randomized controlled trial will compare HGNS alone (n=36) to HGNS plus concomitant LCi (n=36), identifying a modifiable therapeutic target that, when treated, could significantly improve HGNS success rates in a large group of patients who are the most challenging to manage with HGNS. ● In Aim 3, utilizing data collected in Aims 1 and 2 (n=136), we will apply our method of estimating lateral collapse non-invasively using ‘airflow shapes’ to identify HGNS successes/responders. If successful, this will enable early identification of patients who are most suitable for HGNS alone, or may exhibit reduced HGNS efficacy, due to laterally directed obstruction. Overall, our proposal will demonstrate that lateral pharyngeal collapse is the anatomic cause of HGNS failure, which can be identified non-invasively using airflow captured on the clinical sleep study and treated in most patients to enhance HGNS treatment response. This work will have a major impact by minimizing the reliance on DISE for HGNS therapy; obviating unnecessary surgeries (i.e., HGNS alone in OPLW patients); and establishing a modifiable target to mitigate HGNS failure. These outcomes would greatly benefit patients by providing a pathway to completely resolve OSA and associated adverse sequalae.


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 = $894,690 )
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	National Center on Sleep Disorders Research	000	1	7/9/2026	NEW	$894,690
														Subtotal = $894,690

Grand Total All Awards = $894,690

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Recognizing and resolving laterally directed pharyngeal collapse for successful hypoglossal nerve stimulation therapy in OSA

Award Number: R01HL180582

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/03/2026

PERIOD OF PERFORMANCE END DATE: 06/30/2031

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