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Development of a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination

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Abstract

Introduction

A new approach to treat obstructive sleep apnea (OSA) is upper airway stimulation therapy (UAS). Electrical pulses applied to the hypoglossal nerve induce tongue protrusion, increase airway patency and decrease the frequency of apneic and hypopneic events. Thus, the main objective of this study was to design a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination.

Method

This study has designed the Tongue Adverse Event and Satisfaction Questionnaire (TAESQ) and an endobuccal examinations divided into an endobuccal lesion examination (ELE) and an endobuccal risk factor examination (ERFE). Evaluations were conducted at month 6 post-implantation.

Results

The study population after implantation of UAS device consisted of ten Caucasian males with a mean age of 51.9 ± 11.8 years, and a mean BMI of 28.6 ± 3.3. The AHI of the ten participants ranged from 46.7 ± 12.2/h at baseline to 14.5 ± 8.9/h with the Inspire therapy at the 6-month follow-up. The TAESQ revealed pain (30%), followed by less tongue sensitivity (20%) and tongue weakness (10%). The ELE did not reveal any lesions. The ERFE revealed that some participants had tissue and dental risk factors but not associated to more adverse events.

Conclusion

The TAESQ, ELE and ERFE have been designed and studied on a small number of participants. These evaluations could systematically be included in the care pathway of patients treated by UAS to better investigate tongue discomfort and tongue lesion for patients treated with this technology.

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Abbreviations

UAS:

Upper airway stimulation

BMI:

Body Mass Index

AHI:

Apnea Hypopnea Index

OSA:

Obstructive sleep apnea

CPAP:

Continuous positive airway pressure

IPG:

Implantable pulse generator

HGN:

Hypoglossal nerve

STAR:

Stimulation treatment for apnea reduction

TAESQ:

Tongue Adverse Event and Satisfaction Questionnaire

CSQ8:

Client Satisfaction Questionnaire 8

DISE:

Drug-induced sleep endoscopy

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Acknowledgements

This study was possible through a COPSIT grant from the University Hospital of Bordeaux.

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Correspondence to Jean-Arthur Micoulaud-Franchi.

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Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Catella, C., Micoulaud-Franchi, JA., Monteyrol, PJ. et al. Development of a standardized evaluation of endobuccal adverse events induced by repeated tongue protrusion with both a dedicated questionnaire and an endobuccal examination. Eur Arch Otorhinolaryngol 276, 901–909 (2019). https://doi.org/10.1007/s00405-019-05298-8

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  • DOI: https://doi.org/10.1007/s00405-019-05298-8

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