Patient-reported outcome: results of the multicenter German post-market study

Eur Arch Otorhinolaryngol. 2018 Jul;275(7):1913-1919. doi: 10.1007/s00405-018-5017-1. Epub 2018 May 28.

Abstract

Purpose: Upper airway stimulation (UAS) is an alternative second-line treatment option for patients with obstructive sleep apnea (OSA). In our substudy of a previous multicentre study of patients implanted with UAS, we focused on patient-related outcomes like Epworth Sleepiness Scale (ESS), the Functional Outcomes of Sleep Questionnaire (FOSQ), snoring and personal satisfaction 6 and 12 months after the implantation.

Methods: 60 patients, who were initially non-adherent to CPAP and implanted with UAS, were included in a prospective multicentre study. Data were collected preoperative, 6 and 12 months after implantation regarding FOSQ, ESS, snoring, and their experience with the UAS device.

Results: Besides relevant Apnoea-Hypopnea Index (AHI) reduction, we saw significant improvements in ESS (p < 0.001), FOSQ (p < 0.001) and snoring under UAS therapy. A strong correlation between AHI results postoperative and the personal satisfaction of the patients after implantation was found as well as between usage results and AHI compared to the preoperative results.

Conclusion: The more the patients benefit from UAS according to their self-reported outcome, the higher is the therapy use.

Keywords: CPAP failure; Obstructive sleep apnea (OSA); Upper airway stimulation (UAS).

Publication types

  • Clinical Trial, Phase IV
  • Multicenter Study

MeSH terms

  • Adult
  • Electric Stimulation Therapy / instrumentation*
  • Female
  • Germany
  • Humans
  • Larynx / physiopathology
  • Male
  • Middle Aged
  • Patient Reported Outcome Measures
  • Patient Satisfaction
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Self Report
  • Sleep Apnea, Obstructive / complications
  • Sleep Apnea, Obstructive / physiopathology
  • Sleep Apnea, Obstructive / therapy*
  • Snoring / etiology
  • Snoring / prevention & control
  • Surveys and Questionnaires
  • Treatment Outcome