Evidence map›Paper›PMID 41690459›Full record

Trial reportChest2026

Three-Year Outcomes of Proximal Hypoglossal Nerve Stimulation in OSA.

Alan R Schwartz, Ofer Jacobowitz, Samuel A Mickelson, Mitchell B Miller, Arie Oliven, Victor Certal, Martin L Hopp, David H Winslow, Tod C Huntley, Nathan E Nachlas and 8 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Chest, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02263859 (ImThera Medical Targeted Hypoglossal Neurostimulation Study #3), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT02263859 nacompletednot on this map

ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

TypeinterventionalSponsorImThera Medical, Inc.Ran2015 to 2023Enrolled138ConditionsObstructive Sleep ApneaArmsaura6000 System
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Redefining Obstructive Sleep Apnea: Treatment in the Modern Era.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    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

18 authors.

Alan R SchwartzDepartment of Otorhinolaryngology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA; Department of Otolaryngology, Vanderbilt University School of Medicine, Nashville, TN. Electronic address: aschwar02@gmail.com.
Ofer JacobowitzSleep Department, ENT and Allergy Associates, New York, NY.
Samuel A MickelsonAdvanced Ear Nose & Throat Associates, The Atlanta Snoring & Sleep Disorders Institute, Atlanta, GA.
Mitchell B MillerENT Associates, Clearwater, FL.
Arie OlivenDepartment of Medicine, Bnai-Zion Medical Centre, and Rappaport School of Medicine, Technion Institute of Technology, Haifa, Israel.
Victor CertalDepartment of Otorhinolaryngology/Sleep Medicine Centre, Hospital CUF Porto & CHEDV, Portugal, and CINTESIS-Center for Research in Health Technologies and Information Systems, University of Porto, Porto, Portugal.
Martin L HoppDepartment of Otolaryngology-Head and Neck Surgery, Cedars-Sinai Medical Center, Los Angeles, CA.
David H WinslowNorton Clinical Research Group, Louisville, KY.
Tod C HuntleyCenter for Ear, Nose, Throat and Allergy, Carmel, IN.
Nathan E NachlasENT and Allergy Associates of Florida, Boca Raton, FL.
Luu V PhamDivision of Pulmonary and Critical Care Medicine, Johns Hopkins University, Baltimore, MD.
David W EiseleDepartment of Otolaryngology, Head and Neck Surgery, Johns Hopkins University, Baltimore, MD.
M Boyd GillespieDepartment of Otolaryngology-Head and Neck Surgery, University of Tennessee Health Science Center, Memphis, TN.
Brian H WeeksDepartment of Otolaryngology, SENTA Clinic, San Diego, CA.
Eric G LovettClinical and Medical Affairs, LivaNova PLC, Minneapolis, MN.
John ShenOcTech Consulting, St. Paul, MN.
Atul MalhotraPulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of California San Diego, La Jolla, CA.
Joachim T MaurerDivision of Sleep Medicine, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Ruprecht-Karls-University Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTargeted proximal hypoglossal nerve stimulation was shown to improve sleep-disordered breathing, sleep architecture, and quality of life (QOL) with a favorable safety profile over 1 year in the Targeted Hypoglossal Stimulation 3 (THN3) randomized controlled trial. Herein, THN3 proximal hypoglossal nerve stimulation (pHGNS) 3-year safety and efficacy are profiled with reference to distal hypoglossal nerve stimulation (dHGNS) from the Stimulation Therapy for Apnea Reduction (STAR) trial. RESEARCH QUESTION: What are the long-term safety and efficacy of pHGNS, and how do they compare with dHGNS? STUDY DESIGN AND

methodsTHN3 (NCT02263859) enrollees had an apnea-hypopnea index (AHI) 20-65/hr and BMI ≤ 35 kg/m

resultsOne hundred four of 138 (75%) THN3 participants completed 3-year follow-up. pHGNS delivered sustained improvements in sleep-disordered breathing, oxygenation, and QOL at months 24 and 36 vs baseline. Long-term outcomes were comparable to those at 11 months of treatment: median AHI reductions were -15.1/h (95% CI, -18.6, -12.6) and -17.7/h (-21.9, -15.3) with large effect sizes; probabilities of superiority vs baseline were 0.79 (0.72-.87) and 0.79 (0.70-.87), respectively. Benefits in sleep-disordered breathing and QOL were sustained at 36 months and appeared to be comparable to those reported for dHGNS at 3 years.

interpretationTherapeutic responses to pHGNS at 1 year were maintained through 3 years with relatively few adverse events. Similarities in responses to dHGNS suggest that pHGNS provides safe and efficacious long-term OSA treatment. CLINICAL

trial registrationClinicalTrials.gov; No.: NCT02263859; URL: www. CLINICALTRIALS: gov.

Indexed as

Electric Stimulation TherapyHypoglossal NerveSleep Apnea, ObstructiveAdultFemaleFollow-Up StudiesHumansMaleMiddle AgedPolysomnographyQuality of LifeTreatment Outcomeapnea-hypopnea indexhypoglossal nerve stimulationimplantable pulse generatorobstructive sleep apneaproximal hypoglossal nerve stimulationrandomized controlled trialsleep apnea surgeryupper airway neurostimulation

Identifiers

PMID41690459
PMCPMC13197969

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.