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

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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.

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Acknowledgements

We are in debt to all participants of this study for their dedication to clinical research. Sleep technologists Sabrina Wenzel, Oliver Schmidt, Christian Lange, Gudrun Bunk were instrumental in overnight titration studies.

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Authors and Affiliations

  1. Department of Otorhinolaryngology, University of Lübeck, Ratzeburger Allee, 23538, Lübeck, Germany

    Katrin Hasselbacher & A. Steffen

  2. Department of Otorhinolaryngology, Head and Neck Surgery, Klinikum rechts der Isar, Munich, Germany

    B. Hofauer & C. Heiser

  3. Department of Otorhinolaryngology, Head and Neck Surgery, University-Hospital Mannheim, Mannheim, Germany

    J. T. Maurer & J. U. Sommer

Authors
  1. Katrin Hasselbacher
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  2. B. Hofauer
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  3. J. T. Maurer
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  4. C. Heiser
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  5. A. Steffen
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  6. J. U. Sommer
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Corresponding author

Correspondence to Katrin Hasselbacher.

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Financial disclosure

This study is sponsored by Inspire Medical Systems, Inc.

Conflict of interest

Katrin Hasselbacher received personal fees and travel expenses from Inspire Medical Systems. Benedikt Hofauer received personal fees and travel expenses from Inspire Medical Systems. Armin Steffen has received reimbursement of conference fees and travel and accommodation expenses, fees for preparing scientific continuing professional development or other events, funding for research he himself initiated, and fees for conducting clinical studies on related subjects from Inspire Medical Systems, and Resmed. Joachim T. Maurer has received consultancy fees, reimbursement of conference fees and travel expenses, honoraria for scientific lectures and surgical training from Neuwirth Medical, ImThera Medical, Heinen & Löwenstein, Revent Medical, MedEl, Philips, Sissel, Inspire Medical Systems, and Nyxoah. Clemens Heiser is a consultant for Inspire Medical Systems. Clemens Heiser received reimbursement of conference fees and travel and accommodation expenses from Inspire Medical Systems, Neuwirth Medical Products, Heinen & Löwenstein and Sutter Medizintechnik. Clemens Heiser received consultancy fees from Inspire Medical Systems and Sutter Medizintechnik. J. Ulrich Sommer has received consultancy fees, reimbursement of conference fees and travel and accommodation expenses, fees for preparing scientific continuing professional development or other events, funding for research he himself initiated, and fees for conducting clinical studies on related subjects from Neuwirth Medical, ImThera Medical, Fisher & Paykel Healthcare, Heinen & Löwenstein, Medtronic, Revent Medical, MedEl, Philips, Meda Pharma, Inspire Medical Systems, and Nyxoah.

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Hasselbacher, K., Hofauer, B., Maurer, J.T. et al. Patient-reported outcome: results of the multicenter German post-market study. Eur Arch Otorhinolaryngol 275, 1913–1919 (2018). https://doi.org/10.1007/s00405-018-5017-1

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  • DOI: https://doi.org/10.1007/s00405-018-5017-1

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