Evidence map›Paper›PMID 31485853›Full record

Trial reportSleep & breathing = Schlaf & Atmung2020

Long-term follow-up of the German post-market study for upper airway stimulation for obstructive sleep apnea.

Armin Steffen, Ulrich J Sommer, Joachim T Maurer, Nils Abrams, Benedikt Hofauer, Clemens Heiser

Abstract readClinical Trial, Phase IVMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
3.0field-weighted citation impact, top 8% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.

  1. Patient-reported outcomes with hypoglossal nerve stimulation for treatment of obstructive sleep apnea: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2023
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Use of Hypoglossal Nerve Stimulation for Treating OSA in Military Patient Populations.Federal practitioner : for the health care professionals of the VA, DoD, and PHS · 2024
    Review
  9. Article
  10. International Consensus Statement on Obstructive Sleep Apnea.International forum of allergy & rhinology · 2023
    Review
  11. Article
  12. Review
  13. Home sleep apnea testing with peripheral arterial tonometry to assess outcome in upper airway stimulation.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
  14. Article
  15. Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea in Spain: Implementation Strategy and Early Results in a Tertiary Care Center.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2022
    Article
  16. Hypoglossal nerve stimulation for obstructive sleep apnea: updated position paper of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Review
  17. Article
  18. Article
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

6 authors at 5 institutions in 1 country.

Armin SteffenDepartment of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany. armin.steffen@uksh.de.ORCID http://orcid.org/0000-0002-1044-492X
Ulrich J SommerDepartment of Otorhinolaryngology, Head and Neck Surgery, Helios University Hospital Wuppertal, University Witten/Herdecke, Wuppertal, Germany.
Joachim T MaurerDepartment of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany.
Nils AbramsDepartment of Otorhinolaryngology, University of Lübeck, Klinik für HNO-Heilkunde, Ratzeburger Allee 160, 23538, Lübeck, Germany.
Benedikt HofauerDepartment of Otorhinolaryngology, University of Freiburg, Kilianstraße 5, 79106, Freiburg, Germany.
Clemens HeiserDepartment of Otorhinolaryngology, Head and Neck Surgery, Technische Universität München, Munich, Germany.
University of Lübeck · DEHeidelberg University · DEHelios Universitätsklinikum Wuppertal · DETechnical University of Munich · DEUniversity of Freiburg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeUpper airway stimulation (UAS) is an effective treatment for obstructive sleep apnea (OSA) in positive airway pressure (PAP) failure. Most reports have presented short-term data, so long-term safety and efficacy reports are rare. The German post-market study (G-PMS) has followed approximately 60 patients from three implanting centers for several years.

methodsPatients with OSA and PAP failure qualified for the G-PMS by the absence of obesity class 2 an AHI between 15 and 65 events/h and absence of complete concentric collapse at the velum during drug-induced sleep endoscopy. Optional 2- and 3-year follow-ups after implantation were collected during routine clinical practice. We measured respiratory parameters such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) and daytime sleepiness using the Epworth sleepiness scale (ESS) in a per protocol analysis. Usage was calculated from device-downloaded reports. Device-related complications were documented.

resultsOf the 60 original patients, 41 returned for 2-year follow-up, and 38 for 3 years. About 76% at 2 years and 68% at 3 years met the criterion of therapy success defined as an AHI below 15/h. The median AHI was reduced from 28.6/h (baseline) to 9.0/h (2 years) and 10.0/h (3 years); whereas median ODI decreased from 27.0 to 6.3/h (2 years), and 8.3/h (3 years). Median ESS improved from baseline 13 points to 4 (2 years) and 6 (3 years). Usage was stable at approximately 45 h per week at 2 and 3 years. Serious device-related adverse events were rare, with two-device explantation between 12 to 36 months postoperatively.

conclusionsThe German multi-center long-term outcomes compare favorably with previously published studies. Respiratory and sleepiness efficacy outcomes were sustained over 2 and 3 years, with a favorable safety profile, supporting the safety and efficacy of a chronic implantable therapy.

Indexed as

Electric Stimulation TherapyHypoglossal NerveImplantable NeurostimulatorsOutcome Assessment, Health CareAdultAgedBody Mass IndexFemaleFollow-Up StudiesGermanyHumansMaleMiddle AgedPolysomnographyProduct Surveillance, PostmarketingSeverity of Illness IndexDeviceHypoglossal nerve stimulationLong termObstructive sleep apneaPAP failureSurgeryUpper airway stimulation

Identifiers

PMID31485853
OpenAlexW2971731412

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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 Socratic graph.