Evidence map›Paper›PMID 28567688›Full record

Trial reportSleep & breathing = Schlaf & Atmung2017

Effects of upper-airway stimulation on sleep architecture in patients with obstructive sleep apnea.

Benedikt Hofauer, Pierre Philip, Markus Wirth, Andreas Knopf, Clemens Heiser

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02293746 (Inspire® Upper Airway Stimulation), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
3.1field-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.

NCT02293746 phase4completednot on this map

Inspire® Upper Airway Stimulation (UAS) System German Post-Market Study: CE Certificate Number 562872

TypeinterventionalSponsorInspire Medical Systems, Inc.Ran2014 to 2017Enrolled60ConditionsObstructive Sleep ApneaArmsInspire® Upper Airway Stimulation (UAS) System
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 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. Trial
  3. Patient-reported outcome: results of the multicenter German post-market study.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 · 2018
    Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Surgical treatment for obstructive sleep apnea: effect on sleep architecture.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
    Observational
  9. International Consensus Statement on Obstructive Sleep Apnea.International forum of allergy & rhinology · 2023
    Review
  10. Article
  11. Article
  12. Article
  13. Factors affecting obstructive sleep apnea patients' use of upper airway stimulation treatment.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Article
  14. Article
  15. Hypoglossal Nerve Stimulation Therapy.Advances in experimental medicine and biology · 2022
    Article
  16. Article
  17. Hypoglossal nerve stimulation therapy does not alter tongue protrusion strength and fatigability in obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020
    Article
  18. Article
  19. Article
  20. 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

5 authors at 2 institutions in 2 countries.

Benedikt HofauerOtorhinolaryngology / Head and Neck Surgery, Klinikum rechts der Isar, Technical University Munich, Ismaningerstr. 22, 81675, Munich, Germany. b.hofauer@tum.de.ORCID http://orcid.org/0000-0002-3126-2877
Pierre PhilipClinique du Sommeil, CHU Bordeaux-Pellegrin, Bordeaux, France.
Markus WirthOtorhinolaryngology / Head and Neck Surgery, Klinikum rechts der Isar, Technical University Munich, Ismaningerstr. 22, 81675, Munich, Germany.
Andreas KnopfOtorhinolaryngology / Head and Neck Surgery, Klinikum rechts der Isar, Technical University Munich, Ismaningerstr. 22, 81675, Munich, Germany.
Clemens HeiserOtorhinolaryngology / Head and Neck Surgery, Klinikum rechts der Isar, Technical University Munich, Ismaningerstr. 22, 81675, Munich, Germany.
TUM Klinikum · DEHôpital Pellegrin · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSelective upper-airway stimulation (UAS) is a novel therapy for patients with obstructive sleep apnea (OSA). The aim of this study was to compare changes in sleep architecture during the diagnostic polysomnography and the post-implantation polysomnography in UAS in patients with OSA.

methodsTwenty-six patients who received a UAS device (Inspire Medical Systems) were included. Treatment outcome was evaluated 2 and 3 months after surgery. Data collection included demographics, body mass index (BMI), apnea hypopnea index (AHI), oxygen saturation and desaturation index (ODI), Epworth sleepiness score (ESS), arousal parameter, and sleep patterns.

resultsThe mean age was 60.2 years, 25 patients were male, 1 patient was female. Mean BMI was 29.0 kg/m

conclusionIn conclusion, significant changes in sleep architecture of patients with OSA and sufficient treatment with UAS could be observed. A reduction of the amount of time spent in N1-sleep could be caused by treatment with UAS and the rebound of REM sleep, observed for the first time in a study on UAS, is also a potential marker of the efficacy of UAS on sleep architecture.

trial registrationNCT02293746.

Indexed as

Prostheses and ImplantsFemaleHumansMaleMiddle AgedPolysomnographySleepSleep Apnea, ObstructiveSleep, REMHypoglossal nerve stimulationObstructive sleep apneaSleep apnea treatmentSleep architectureSleep patternSleep surgeryUpper-airway stimulation

Identifiers

PMID28567688
OpenAlexW2620409530

What OpenQuestion holds

Textmetadata
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.