CC BY-NC-ND 4.0 · Laryngorhinootologie 2022; 101(S 02): S243-S244
DOI: 10.1055/s-0042-1747052
Abstracts | DGHNOKHC
Sleeping disorders: Implants / Stimulation therapy

Continuous Targeted Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: A Prospective Randomized, Controlled Trial – THN3

JoachimT. Maurer
1   Universitätsklinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Hals-Chirurgie, Sektion für Schlafmedizin Mannheim
,
SamuelA Mickelson
3   The Atlanta Snoring & Sleep Disorders Institute, Advanced Ear Nose & Throat Associates Atlanta United States
,
MitchelB Miller
4   ENT Associates Clear water United States
,
Arie Oliven
5   Bnai-Zion Medical Centre, Department of Medicine HaifaIsrael
,
Atul Malhotra
7   Department of Medicine, University of California San Diego, Pulmonary, Critical Care, and Sleep MedicineLa Jolla United States
,
Victor Certal
8   Hospital CUF Porto & CHEDV, Department of Otorhinolaryngology/Sleep Medicine Centre Porto Portugal
,
MartinL Hopp
10   Cedars-Sinai Medical Center, Department of Otolaryngology-Head and Neck SurgeryLos Angeles United States
,
DavidH Winslow
11   Norton Clinical Research Group Louisville United States
,
TodC Huntley
12   Center for Ear, Nose, Throat and Allergy Carmel United States
,
Ofer Jacobowitz
13   ENT and Allergy Associates, Sleep Department New York United States
,
NathanE Nachlas
14   Ear, Nose, Throat, and Allergy Associates of Florida Boca Raton United States
,
LuuV Pham
15   Johns Hopkins University, Division of Pulmonary and Critical Care Medicine Baltimore United States
,
MBoyd Gillespie
16   University of Tennessee Health Science Center, Department of Otolaryngology-Head and Neck Surgery Memphis United States
,
BrianH Weeks
17   SENTA Clinic, Department of OtolaryngologySan Diego United States
,
EricG Lovett
18   LivaNova PLC, Clinical and Medical Affairs Minneapolis United States
,
John Shen
19   OcTech Consulting St. Paul United States
,
AlanR Schwartz
20   Perelman School of Medicine, University of Pennsylvania, Department of Otorhinolaryngology Philadelphia United States
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    Introduction Distal hypoglossal nerve stimulation (HGNS) has demonstrated treatment response in patients with obstructive sleep apnea (OSA) without complete concentric retropalatal collapse (CCC). Preliminary studies suggest that targeted HGNS (THN) of the proximal nerve can achieve similar results in a broader range of OSA patients. The present study was designed to establish the safety and efficacy of THN therapy in a randomized, controlled trial (RCT).

    Methods 138 OSA patients with apnea-hypopnea index (AHI) from 20-65/h and BMI≤35 kg/m2 were implanted and randomized 2:1 to activation at Month 1 (“Treatment”) or Month 4 (“Control”). All received therapy for 11 months. Co-primary efficacy endpoints consisted of AHI and oxygen desaturation index responder rates (RRs) at Month 4 and at Months 12/15. RR was defined by a ≥50% AHI reduction to ≤20/h and ≥25% ODI decrease. Secondary endpoints included patient-reported outcomes (Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ) and EQ-5D visual analog scale (VAS) at Month 4).

    Results Subjects were middle-aged (56±9 years), male (86%), and overweight/obese (BMI 30±3 kg/m<sup>2</sup>). Three of four co-primary and all secondary endpoints improved significantly including an AHI RR of 52.3% vs. 19.6%. Differences between Treatment and Control for ESS, FOSQ, and EQ-5D VAS at Month 4 were clinically relevant and significant. AHI median reduction in THN3 was comparable to the STAR trial of distal HGNS (14.4/h at Month 12/15 vs. 17.3/h at Month 12, respectively), despite a higher AHI and BMI and without regard to the presence of CCC.

    CONCLUSIONS: The THN3 RCT of proximal HGNS demonstrated significant, clinically meaningful improvements in sleep apnea and quality of life in an expanded spectrum of OSA patients.

    Conflict of Interest Der Erstautor weist auf folgenden Interessenkonflikt hin Revent Medical: Honorar für Tätigkeit als Operationstutor und Referent, Reisekostenerstattung, klinische Studien, DrittmittelkontenInspire Medical: Honorar für Vortragstätigkeit, Reisekostenerstattung, klinische Studien, DrittmittelkontenImThera/LivaNova: Honorar für Vortragstätigkeit, Reisekostenerstattung, klinische Studien, DrittmittelkontenNyxoah: klinische Studien, Drittmittelkonten, Honorar für Vortragstätigkeit, Reisekostenerstattung, BeratertätigkeitMedEl: Forschungsvorhaben, Reisekostenerstattungen im Rahmen von Studien, klinische Studien, DrittmittelkontenNeuwirth Medical Products: Honorar für Vortragstätigkeit, ReisekostenerstattungXM Consult: Honorar für Vortragstätigkeit, ReisekostenerstattungGramann Veranstaltungsorganisation: Honorar für Vortragstätigkeit, ReisekostenerstattungPura Vida: BeratungstätigkeitRG Gesellschaft für Information und Organisation: Honorar für Vortragstätigkeit, ReisekostenerstattungAkadamie für Schlafmedizin: Honorar für Vortragstätigkeit, ReisekostenerstattungDeutsche Gesellschaft für Schlafforschung und Schlafmedizin: Reisekostenerstattungen, Erlass der Teilnahmegebühren für ReferentenÄrztekammer Westfalen-Lippe: Honorar für Vortragstätigkeit/KursmaterialienDresden International University: Honorar für Lehrauftrag, Reisekostenerstattung Forum Otorhinolaryngologicum: Honorar für Vortragstätigkeit, ReisekostenerstattungFortbildungsgemeinschaft des Berufsverbands der HNO-Ärzte: Honorar für Vortragstätigkeit, ReisekostenerstattungContinentale Versicherung: Honorar für Vortragstätigkeit, Reisekostenerstattung


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    Conflict of Interest

    The author declares that there is no conflict of interest.

    Publication History

    Article published online:
    24 May 2022

    © 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).

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