Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial

B Tucker Woodson; David T Kent; Colin Huntley; Melyssa K Hancock; Douglas J Van Daele; Maurits S Boon; Tod C Huntley; Sam Mickelson; M Boyd Gillespie; Maria V Suurna; Ashutosh Kacker; Asim Roy; Stuart MacKay; Kirk P Withrow; Raj C Dedhia; Phillip Huyett; Clemens Heiser; Sylvie di Nicola; Fatima Makori; Olivier M Vanderveken; Tapan A Padyha; Ulysses J Magalang; Eugene Chio; Eric J Kezirian; Richard Lewis

doi:10.5664/jcsm.11822

Back

Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial

Journal article

Open access

Peer reviewed

Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial

B Tucker Woodson, David T Kent, Colin Huntley, Melyssa K Hancock, Douglas J Van Daele, Maurits S Boon, Tod C Huntley, Sam Mickelson, M Boyd Gillespie, Maria V Suurna, …

Journal of clinical sleep medicine, Vol.21(11), pp.1883-1891

11/01/2025

DOI: 10.5664/jcsm.11822

PMCID: PMC12582211

PMID: 40702817

Files and links (1)

url

https://doi.org/10.5664/jcsm.11822View

Published (Version of record) Open Access

Abstract

Study Objectives: To evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNSBL) device for the treatment of OSA. Methods: Adult patients with moderate-to-severe OSA who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNSBL. The co-primary endpoints at 12 months were 1) a minimum of 50% reduction in the 4% apnea-hypopnea index (AHI) from baseline with a final AHI of less than 20 events/h, and 2) a minimum of 25% reduction in the 4% oxygen desaturation index (ODI). Objective secondary endpoints included changes in mean AHI, ODI, and sleep time with blood oxygen saturation less than 90% (T90). Subjective secondary endpoints included changes in Epworth sleepiness score (ESS), the short Functional Outcomes of Sleep Questionnaire (FOSQ-10) score, the Symptoms of Nocturnal Obstruction and Related Events (SNORE-25) score, and bedpartner assessment of snoring. Results: HNSBL was implanted in 113 participants. Eleven SAEs occurred in 10 (8.7%) participants. The co-primary endpoints were completed by 89 (77.4%) participants. AHI and ODI responses were achieved in 63.5% (73/115, p = 0.002) and 71.3% (82/115, p< 0.001), respectively. Secondary endpoint analysis revealed significant changes in mean AHI (-18.3±11.8 events/h, p<0.001), ODI (-17.7±14.6 events/h, p<0.001), and T90 (6.9±10.7%, p<0.001). Significant changes were observed in all secondary endpoints (p<0.001). Conclusions: This pivotal clinical trial of HNSBL demonstrated an acceptable safety profile with clinically significant improvements in OSA severity and quality-of-life metrics. HNSBL is a promising new treatment option for select patients with OSA. Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); Identifier: NCT03868618; URL: https://clinicaltrials.gov/study/NCT03868618

obstructive sleep apnea

hypoglossal nerve stimulation

sleep surgery

Details

Title: Subtitle: Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial
Creators: B Tucker Woodson - Medical College of Wisconsin
David T Kent - Vanderbilt University Medical Center
Colin Huntley - Thomas Jefferson University
Melyssa K Hancock - ENT and Allergy Associates of Florida
Douglas J Van Daele - University of Iowa
Maurits S Boon - Thomas Jefferson University
Tod C Huntley - ENT and Allergy
Sam Mickelson - Advanced ENT Associates, Atlanta, Georgia
M Boyd Gillespie - University of Tennessee Health Science Center
Maria V Suurna - University of Miami
Ashutosh Kacker - Cornell University
Asim Roy - NE Ohio Medical University, Sleep Medicine Institute, Dublin, OH
Stuart MacKay - Illawarra ENT, Head & Neck Clinic, Wollongong. NSW Australia
Kirk P Withrow - University of Alabama at Birmingham
Raj C Dedhia - University of Pennsylvania
Phillip Huyett - Harvard University
Clemens Heiser - Technical University of Munich
Sylvie di Nicola - Zimmer Biomet (France)
Fatima Makori - Zimmer Biomet (France)
Olivier M Vanderveken - Antwerp University Hospital
Tapan A Padyha - University of South Florida
Ulysses J Magalang - The Ohio State University Wexner Medical Center
Eugene Chio - ENT and Allergy
Eric J Kezirian - University of California, Los Angeles
Richard Lewis - Perth Head & Neck Surgery, Perth, WA, Australia
Resource Type: Journal article
Publication Details: Journal of clinical sleep medicine, Vol.21(11), pp.1883-1891
DOI: 10.5664/jcsm.11822
PMID: 40702817
PMCID: PMC12582211
NLM abbreviation: J Clin Sleep Med
ISSN: 1550-9397
eISSN: 1550-9397
Publisher: American Academy of Sleep Medicine
Grant note: Nyxoah
The authors confirm that the manuscript has been seen and approved by all named authors. The study was conducted at the above-listed institutions. The study is sponsored by Nyxoah. The funder designed and conducted the study; collection of the data was also done by the funder. Management and analysis of the data was done by independent statisticians and verified by the publication committee, along with data interpretation. Preparation, review, or approval of the manuscript and the decision to submit the manuscript for publication was also performed by the publication committee. Dr. Woodson is a consultant for Nyxoah, Medtronic, Linguaflex, and Cryosa, is on the advisory board of Cryosa, received research funding from Nyxoah, Linguaflex, and Medtronic during the course of the study, and is coordinating investigator for DREAM. Dr. Kent is a consultant for Restera; is on the advisory board of Nyxoah; received research funding from Inspire Medical Systems, Nyxoah, Restera; inventor on US and international patents and applications owned by Vanderbilt University and licensed to Nyxoah SA; received research funding from National Heart, Lung, and Blood Institute (NHLBI) (R01HL161635). Dr. C. Huntley is a consultant for Inspire Medical Systems, Nyxoah, Avivomed; received research funding from Inspire Medical Systems, Nyxoah. Dr. Hancock is a consultant for Nyxoah; received research funding from Nyxoah. Dr. Van Daele received research funding from Inspire Medical Systems, Nyxoah, Checkpoint. Dr. Boon is an employee of Nyxoah. Dr. Mickelson is on the advisor board of Zelegent Inc.; received research funding from Nyxoah, Livanova. Dr. Gillespie is a consultant for HuMannity; is on the advisor board of CryOSA; received research funding from Inspire Medical Systems, Nyxoah. Dr. Suurna is a consultant for Nyxoah, Inspire Medical Systems; received research funding from Nyxoah, CryOSA; received honoraria from Nyxoah, Inspire Medical Systems. Dr. Kacker is a consultant for Sanofi, Genzyme; received research funding from Inspire Medical Systems, Nyxoah, Livanova. Dr. Roy received research funding from Nyxoah, Inspire, Takeda, Alkermes, Noctrix, Jazz, Harmony, Apnimed, Avadel, Signifier, Fisher Paykel, Amenity, Zoll/Respicardia; received honoraria from Jazz, Inspire, Harmony, Avadel; received speakership fees from Jazz, Inspire, Harmony, Avadel, Axsome. Dr. Mackay received research funding from National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation 2013 Prabha Seshadri Research Grant; non-financial support from Nyxoah; received grants from Garnett-Passe Rodney Williams Foundation, Illawarra Health and Medical Research Institute. Dr. Withrow is a consultant for Avivomed. Dr. Dedhia is on the advisory board of Lunair; received research funding from Inspire Medical Systems, Nyxoah, CryOSA. Dr. Huyett is a consultant for Inspire Medical Systems (educational grant); received research funding from Inspire Medical Systems, Nyxoah. Prof. Heiser is a consultant for Nyxoah; received research funding from Inspire Medical Systems, Nyxoah, Lowenstein Medizintechnik through Institution; received travel assistance from XM Consult, Inspire Medical Systems and Nyxoah; He is also the founder of Institute for Sleep Medicine. Prof. Vanderveken is a consultant for Inspire Medical Systems; received research funding from ProSomnus, Nyxoah, Inspire Medical Systems, Somnomed; receives a Senior Clinical Fellowship at FWO Research Foundation Flanders, Belgium. Dr. Padhya received research funding from Nyxoah. Dr. Magalang received research funding from NHLBI (R01HL175579); NHLBI (1 P01 HL160471); National Cancer Institute (R21CA276027); Department of Defense-Peer Reviewed Medical Research Program (PR212399). Dr. Chio was a consultant for Inspire Medical Systems and is a consultant for Nyxoah. Dr. Kezirian is a consultant for Nyxoah, huMannity Medtec, Berendo Scientific, Split Rock Scientific, is on the advisory board of Cryosa, and has received research funding from Inspire Medical Systems. Drs. Lewis, T. Huntley, Withrow, Ms. di Nicola and Ms. Makori declare no conflicts of interest.
Language: English
Electronic publication date: 07/24/2025
Date published: 11/01/2025
Academic Unit: Radiation Oncology; Medicine Administration; Otolaryngology
Record Identifier: 9984865437002771

Metrics

23 Record Views