Accuracy and reliability of the sensory test performed using the laryngopharyngeal endoscopic esthesiometer and rangefinder in patients with suspected obstructive sleep apnoea hypopnoea: protocol for a prospective double-blinded, randomised, exploratory study

Luis Fernando Giraldo-Cadavid, Alirio Rodrigo Bastidas, Diana Marcela Padilla-Ortiz, Diana Carolina Concha-Galan, María Angelica Bazurto, Leslie Vargas, Luis Fernando Giraldo-Cadavid, Alirio Rodrigo Bastidas, Diana Marcela Padilla-Ortiz, Diana Carolina Concha-Galan, María Angelica Bazurto, Leslie Vargas

Abstract

Introduction: Patients with obstructive sleep apnoea hypopnoea syndrome (OSA) might have varying degrees of laryngopharyngeal mechanical hyposensitivity that might impair the brain's capacity to prevent airway collapse during sleep. However, this knowledge about sensory compromises in OSA comes from studies performed using methods with little evidence of their validity. Hence, the purpose of this study is to assess the reliability and accuracy of the measurement of laryngopharyngeal mechanosensitivity in patients with OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER).

Methods and analysis: The study will be prospective and double blinded, with a randomised crossover assignment of raters performing the sensory tests. Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a university hospital sleep laboratory. Intra-rater and inter-rater reliability will be evaluated using the Bland-Altman's limits of agreement plot, the intraclass correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on the distribution of the variables. Diagnostic accuracy will be evaluated plotting ROC curves using standard baseline polysomnography as a reference. The sensory threshold values ​​for patients with mild, moderate and severe OSA will be determined and compared using ANOVA or the Kruskal-Wallis test, depending on the distribution of the variables. The LPEER could be a new tool for evaluating and monitoring laryngopharyngeal sensory impairment in patients with OSA. If it is shown to be valid, it could help to increase our understanding of the pathophysiological mechanisms of this condition and potentially help in finding new therapeutic interventions for OSA.

Ethics and dissemination: The protocol has been approved by the Institutional Review Board of Fundacion Neumologica Colombiana. The results will be disseminated through conference presentations and peer-reviewed publication.

Trial registration: This trial was registered at Clinical Trials Accuracy of the sensory test using the lLaryngopharyngeal endoscopic esthesiometer in obstructive sleep apnea. Protocol ID: 201611-22405. ClinicalTrials.gov ID: NCT03109171.

Keywords: adult thoracic medicine; bronchoscopy; laryngology; sleep medicine.

Conflict of interest statement

Competing interests: The laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER), which will be validated in this study, was granted a patent by the Superintendencia de Industria y Comercio de Colombia and a Patent Cooperation Treaty (PCT) by the World Intellectual Property Organization. The financial rights of the patent belong to University of La Sabana (one of this study’s funders). LFGC is one of the inventors of LPEER and could potentially receive future royalties from this patent. The study funders will not participate in the conduction of the study, statistical analysis, writing of the manuscript or decision to submit the report for publication.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Flowchart of the study.

References

    1. Miyaji H, Hironaga N, Umezaki T, et al. . Neuromagnetic detection of the laryngeal area: sensory-evoked fields to air-puff stimulation. Neuroimage 2014;88:162–9. 10.1016/j.neuroimage.2013.11.008
    1. Nguyen AT, Jobin V, Payne R, et al. . Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep 2005;28:585–93. 10.1093/sleep/28.5.585
    1. Aviv JE, Martin JH, Sacco RL, et al. . Supraglottic and pharyngeal sensory abnormalities in stroke patients with dysphagia. Ann Otol Rhinol Laryngol 1996;105:92–7. 10.1177/000348949610500202
    1. Aviv JE, Sacco RL, Mohr JP, et al. . Laryngopharyngeal sensory testing with modified barium swallow as predictors of aspiration pneumonia after stroke. Laryngoscope 1997;107:1254–60. 10.1097/00005537-199709000-00018
    1. Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet 2014;383:736–47. 10.1016/S0140-6736(13)60734-5
    1. Teramoto S, Sudo E, Matsuse T, et al. . Impaired swallowing reflex in patients with obstructive sleep apnea syndrome. Chest 1999;116:17–21. 10.1378/chest.116.1.17
    1. Valbuza JS, de Oliveira MM, Zancanella E, et al. . Swallowing dysfunction related to obstructive sleep apnea: a nasal fibroscopy pilot study. Sleep Breath 2011;15:209–13. 10.1007/s11325-010-0474-9
    1. Oliveira LA, Fontes LH, Cahali MB. Swallowing and pharyngo-esophageal manometry in obstructive sleep apnea. Braz J Otorhinolaryngol 2015;81:294–300. 10.1016/j.bjorl.2015.03.006
    1. Chien MY, Wu YT, Lee PL, et al. . Inspiratory muscle dysfunction in patients with severe obstructive sleep apnoea. Eur Respir J 2010;35:373–80. 10.1183/09031936.00190208
    1. Tsai YJ, Ramar K, Liang YJ, et al. . Peripheral neuropathology of the upper airway in obstructive sleep apnea syndrome. Sleep Med Rev 2013;17:161–8. 10.1016/j.smrv.2012.05.005
    1. Eckert DJ, Lo YL, Saboisky JP, et al. . Sensorimotor function of the upper-airway muscles and respiratory sensory processing in untreated obstructive sleep apnea. J Appl Physiol 2011;111:1644–53. 10.1152/japplphysiol.00653.2011
    1. Fogel RB, Malhotra A, Shea SA, et al. . Reduced genioglossal activity with upper airway anesthesia in awake patients with OSA. J Appl Physiol 2000. 2000;88:1346–54.
    1. Maurer JT, Van de Heyning P, Lin H-S, et al. . Operative technique of upper airway stimulation: an implantable treatment of obstructive sleep apnea. Oper Tech Otolayngol Head Neck Surg 2012;23:227–33. 10.1016/j.otot.2012.07.002
    1. Wozniak DR, Lasserson TJ, Smith I. Educational, supportive and behavioural interventions to improve usage of continuous positive airway pressure machines in adults with obstructive sleep apnoea. Cochrane Database Syst Rev 2014;1:CD007736 10.1002/14651858.CD007736.pub2
    1. Breekveldt-Postma NS, Gerrits CM, Lammers JW, et al. . Persistence with inhaled corticosteroid therapy in daily practice. Respir Med 2004;98:752–9. 10.1016/j.rmed.2004.01.014
    1. Bender BG, Pedan A, Varasteh LT. Adherence and persistence with fluticasone propionate/salmeterol combination therapy. J Allergy Clin Immunol 2006;118:899–904. 10.1016/j.jaci.2006.07.002
    1. Gamble J, Stevenson M, McClean E, et al. . The prevalence of nonadherence in difficult asthma. Am J Respir Crit Care Med 2009;180:817–22. 10.1164/rccm.200902-0166OC
    1. Kezirian EJ, Boudewyns A, Eisele DW, et al. . Electrical stimulation of the hypoglossal nerve in the treatment of obstructive sleep apnea. Sleep Med Rev 2010;14:299–305. 10.1016/j.smrv.2009.10.009
    1. Gillick BT, Zirpel L. Neuroplasticity: an appreciation from synapse to system. Arch Phys Med Rehabil 2012;93:1846–55. 10.1016/j.apmr.2012.04.026
    1. Page SJ, Cunningham DA, Plow E, et al. . It takes two: noninvasive brain stimulation combined with neurorehabilitation. Arch Phys Med Rehabil 2015;96(4 Suppl):S89–93. 10.1016/j.apmr.2014.09.019
    1. Robbins SM, Houghton PE, Woodbury MG, et al. . The therapeutic effect of functional and transcutaneous electric stimulation on improving gait speed in stroke patients: a meta-analysis. Arch Phys Med Rehabil 2006;87:853–9. 10.1016/j.apmr.2006.02.026
    1. Howlett OA, Lannin NA, Ada L, et al. . Functional electrical stimulation improves activity after stroke: a systematic review with meta-analysis. Arch Phys Med Rehabil 2015;96:934–43. 10.1016/j.apmr.2015.01.013
    1. Gallas S, Marie JP, Leroi AM, et al. . Sensory transcutaneous electrical stimulation improves post-stroke dysphagic patients. Dysphagia 2010;25:291–7. 10.1007/s00455-009-9259-3
    1. Rofes L, Arreola V, López I, et al. . Effect of surface sensory and motor electrical stimulation on chronic poststroke oropharyngeal dysfunction. Neurogastroenterol Motil 2013;25:888–e701. 10.1111/nmo.12211
    1. Speyer R, Baijens L, Heijnen M, et al. . Effects of therapy in oropharyngeal dysphagia by speech and language therapists: a systematic review. Dysphagia 2010;25:40–65. 10.1007/s00455-009-9239-7
    1. Pauloski BR, Logemann JA, Rademaker AW, et al. . Effects of enhanced bolus flavors on oropharyngeal swallow in patients treated for head and neck cancer. Head Neck 2013;35:1124–31. 10.1002/hed.23086
    1. Aviv JE, Martin JH, Keen MS, et al. . Air pulse quantification of supraglottic and pharyngeal sensation: a new technique. Ann Otol Rhinol Laryngol 1993;102:777–80. 10.1177/000348949310201007
    1. Aviv JE, Martin JH. 2000. Apparatus and method to objectively measure sensory discrimination thresholds in the upper aero digestive tract. 1 Nov 1995. United States patent US6036655.
    1. Cunningham JJ, Halum SL, Butler SG, et al. . Intraobserver and interobserver reliability in laryngopharyngeal sensory discrimination thresholds: a pilot study. Ann Otol Rhinol Laryngol 2007;116:582–8. 10.1177/000348940711600805
    1. Hammer MJ. Design of a new somatosensory stimulus delivery device for measuring laryngeal mechanosensory detection thresholds in humans. IEEE Trans Biomed Eng 2009;56:1154–9. 10.1109/TBME.2008.2007968
    1. Giraldo-Cadavid LF, Burguete J, Rueda F, et al. . Reliability of a laryngo-pharyngeal esthesiometer and a method for measuring laryngo-pharyngeal mechano-sensitivity in a prospectively recruited cohort of patients. Eur Arch Otorhinolaryngol 2017;274:2861–70. 10.1007/s00405-017-4536-5
    1. Giraldo-Cadavid LF, Agudelo-Otalora LM, Burguete J, et al. . Design, development and validation of a new laryngo-pharyngeal endoscopic esthesiometer and range-finder based on the assessment of air-pulse variability determinants. Biomed Eng Online 2016;15:1–23. 10.1186/s12938-016-0166-1
    1. Giraldo-Cadavid LF, Burguete J, Rueda F, et al. , 20 May 2015. Accuracy of the laryngeal adductor reflex explored by a New Laryngo-Pharyngeal Esthesiometer during the Fiberoptic Endoscopic evaluation of swallowing. American Thoracic Society - ATS 2015 International Conference
    1. Giraldo-Cadavid LF, Agudelo-Otalora M, Arbulu M, et al. . 2014. Universidad de La Sabana, assignee. Apparatus for measuring sensory thresholds in the laryngeal/pharyngeal tract of a patient. Colombia patent 13-1212843.
    1. Larsson H, Carlsson-Nordlander B, Lindblad LE, et al. . Temperature thresholds in the oropharynx of patients with obstructive sleep apnea syndrome. Am Rev Respir Dis 1992;146:1246–9. 10.1164/ajrccm/146.5_Pt_1.1246
    1. Fruhstorfer H, Lindblom U, Schmidt WC. Method for quantitative estimation of thermal thresholds in patients. J Neurol Neurosurg Psychiatry 1976;39:1071–5. 10.1136/jnnp.39.11.1071
    1. Goldberg JM, Lindblom U. Standardised method of determining vibratory perception thresholds for diagnosis and screening in neurological investigation. J Neurol Neurosurg Psychiatry 1979;42:793–803. 10.1136/jnnp.42.9.793
    1. Kimoff RJ, Sforza E, Champagne V, et al. . Upper airway sensation in snoring and obstructive sleep apnea. Am J Respir Crit Care Med 2001;164:250–5. 10.1164/ajrccm.164.2.2010012
    1. Streiner DL, Norman GR, Reliability CJ, Health measurement scales a practical guide to their development and use. 5th ed Oxford: United Kingdom: Oxford University Press, 2015:159–99.
    1. Streiner DL, Norman GR, Cairney J. Generalizability theory : Streiner DL, Norman GR, Cairney J, Health measurement scales a practical guide to their development and use. 5th edn Oxford, United Kingdom: Oxford University Press, 2015:199–226.
    1. Müller R, Büttner P. A critical discussion of intraclass correlation coefficients. Stat Med 1994;13(23-24):2465–76. 10.1002/sim.4780132310
    1. Giraldo-Cadavid LF. Endoscopic Laryngopharyngeal Sensory Test (ELST) Protocol for the validation of a Laryngo-Pharyngeal Endoscopic Esthesiometer and Rangefinder (LPEER). 2016. (accessed 27 Aug 2016).
    1. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;33:159–74. 10.2307/2529310
    1. Sharrack B, Hughes RA, Soudain S, et al. . The psychometric properties of clinical rating scales used in multiple sclerosis. Brain 1999;122:141–59. 10.1093/brain/122.1.141
    1. Sheskin DJ. Measures of Association/Correlation Handbook of Parametric and Nonparametric Statistical Procedures. 3rd edn Florida, USA: CRC Press, 2003:943–1120.
    1. Hosmer DW, Lemeshow S. Assessing the fit of the model : Hosmer DW, Lemeshow S, Applied Logistic regression. 2nd edn New York: John Wiley & Sons, Inc, 2000.
    1. Bonett DG. Sample size requirements for estimating intraclass correlations with desired precision. Stat Med 2002;21:1331–5. 10.1002/sim.1108
    1. Machin D, Campbell MJ, Tan SB, et al. . Sample size tables for clinical studies. 3rd edn West Sussex, UK: Wiley-Blackwell, 2009.
    1. Machin D, Campbell MJ, Tan SB, et al. . Reference intervals and receiver operating curves : Machin D, Campbell MJ, Tan SB, Sample size tables for clinical studies. 3rd edn West Sussex, UK: Wiley-Blackwell, 2009:158–78.
    1. Nacci A, Ursino F, La Vela R, et al. . Fiberoptic endoscopic evaluation of swallowing (FEES): proposal for informed consent. Acta Otorhinolaryngol Ital 2008;28:206–11.
    1. Aviv JE, Kaplan S, Langmore SE. The safety of endoscopic swallowing evaluations Langmore SE, Endoscopic evaluation and treatment of swallowing disorders. 1st edn New York: Thieme, 2001:235–41.
    1. Aviv JE, Murry T, Zschommler A, et al. . Flexible endoscopic evaluation of swallowing with sensory testing: patient characteristics and analysis of safety in 1,340 consecutive examinations. Ann Otol Rhinol Laryngol 2005;114:173–6. 10.1177/000348940511400301

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