Evidence map›Paper›PMID 40702817›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2025

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 and 15 more

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03868618 naactive not recruitingnot on this map

A Multicenter Study to Assess the Safety and Effectiveness of the Genio Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Adults Subjects

TypeinterventionalSponsorNyxoah S.A.Ran2020 to 2028Enrolled115ConditionsObstructive Sleep ApneaArmsGenio™ system
NCT07331285 recruitingnot on this mapstarted 2026, after this paper: background citation

Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation

TypeobservationalSponsorNyxoah Inc.Ran2026 to 2032Enrolled229ConditionsObstructive Sleep ApneaArmsThis is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Reply to "Clinical pathway implications of bilateral hypoglossal nerve stimulation for PAP-intolerant OSA".Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
    Article
  6. Clinical pathway implications of bilateral hypoglossal nerve stimulation for PAP-intolerant OSA.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
    Article
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

B Tucker WoodsonMedical College Wisconsin, Milwaukee, Wisconsin.
David T KentVanderbilt Univ. Medical Center, Nashville, Tennessee.
Colin HuntleyThomas Jefferson University, Philadelphia, Pennsylvania.
Melyssa K HancockENT & Allergy Associates of Florida, Boca Raton, Florida.
Douglas J Van DaeleUniversity of Iowa, Iowa City, Iowa.
Maurits S BoonThomas Jefferson University, Philadelphia, Pennsylvania.
Tod C HuntleyCenter for ENT & Allergy, Carmel, Indiana.
Sam MickelsonAdvanced ENT Associates, Atlanta, Georgia.
M Boyd GillespieThe University of Tennessee Health Science Center, Memphis, Tennessee.
Maria V SuurnaUniversity of Miami Medical Center, Miami, Florida.
Ashutosh KackerWeill Cornell Medicine, New York, New York.
Asim RoySleep Medicine Institute, Nebraska Ohio Medical University, Dublin, Ohio.
Stuart MacKayHead & Neck Clinic, Illawarra ENT, Wollongong, New South Wales, Australia.
Kirk P WithrowUniversity of Alabama at Birmingham, Birmingham, Alabama.
Raj C DedhiaUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Phillip HuyettHarvard University, Mass Eye & Ear, Boston, Massachusetts.
Clemens HeiserTechnische Universitat Munchen, München, Germany.
Sylvie di NicolaInferential Premium Biometry, Paris, France.
Fatima MakoriInferential Premium Biometry, Paris, France.
Olivier M VandervekenFaculty of Medicine, Translational Neurosciences, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium.
Tapan A PadyhaUniversity of South Florida, Tampa, Florida.
Ulysses J MagalangThe Ohio State University Wexner Medical Center, Columbus, Ohio.
Eugene ChioOhio ENT and Allergy Physicians, Columbus, Ohio.
Eric J KezirianDepartment of Head and Neck Surgery, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Richard LewisPerth Head & Neck Surgery, Perth, Western Australia, Australia.

Funding

MicroRNAs as Biomarkers for Obstructive Sleep ApneaP01HL160471 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI Allan I Pack · 2023 to 2026
$11.9M
The Effect of Ansa Cervicalis Neurostimulation on Airway Patency in Obstructive Sleep ApneaR01HL161635 · NHLBI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI David T. Kent · 2022 to 2026
$3.9M
Undiagnosed Obstructive Sleep Apnea in Primary Care ClinicsR01HL175579 · NHLBI · OHIO STATE UNIVERSITY · PI ULYSSES J MAGALANG, Allan I Pack · 2024 to 2026
$2.3M
Mechanism Underlying Sleep Disruption by Mammary TumorsR21CA276027 · NCI · WEST VIRGINIA UNIVERSITY · PI DEVRIES, ANNE COURTNEY, NELSON, RANDY J. · 2023 to 2024
$382k
NCI NIH HHS R21 CA276027NHLBI NIH HHS P01 HL160471NHLBI NIH HHS R01 HL161635NHLBI NIH HHS R01 HL175579
6 · The paper itself

Abstract

STUDY

objectivesTo evaluate the safety and efficacy of a novel bilateral hypoglossal nerve stimulation (HNS

methodsAdult patients with moderate-to-severe obstructive sleep apnea who refused, failed, or did not tolerate positive airway pressure therapy underwent implantation and nightly use of HNS

resultsHNS

conclusionsThis pivotal clinical trial of HNS CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Dual-sided Hypoglossal NeRvE StimulAtion for the TreatMent of Obstructive Sleep Apnea (DREAM); URL: https://clinicaltrials.gov/study/NCT03868618; Identifier: NCT03868618. CITATION: Woodson BT, Kent DT, Huntley C, et al. Bilateral hypoglossal nerve stimulation for obstructive sleep apnea: a nonrandomized clinical trial.

Indexed as

Electric Stimulation TherapyHypoglossal NerveSleep Apnea, ObstructiveAdultAgedFemaleHumansMaleMiddle AgedPolysomnographySeverity of Illness IndexTreatment Outcomehypoglossal nerve stimulationobstructive sleep apneasleep surgery

Identifiers

PMID40702817
PMCPMC12582211

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.