1. 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
- Author
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Luis Fernando Giraldo-Cadavid, Diana Padilla-Ortiz, Diana Carolina Concha-Galan, María Angélica Bazurto, Leslie Vargas, and Alirio Bastidas
- Subjects
adult thoracic medicine ,medicine.medical_specialty ,bronchoscopy ,Laryngology ,Intraclass correlation ,Polysomnography ,0206 medical engineering ,02 engineering and technology ,laryngology ,Colombia ,Sleep medicine ,Hospitals, University ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,medicine ,Protocol ,Humans ,Prospective Studies ,Prospective cohort study ,Respiratory Medicine ,Sleep Apnea, Obstructive ,Cross-Over Studies ,Receiver operating characteristic ,medicine.diagnostic_test ,business.industry ,sleep medicine ,Reproducibility of Results ,Endoscopy ,General Medicine ,medicine.disease ,020601 biomedical engineering ,Clinical trial ,Obstructive sleep apnea ,ROC Curve ,Research Design ,Sensory Thresholds ,Physical therapy ,Pharynx ,Larynx ,business ,030217 neurology & neurosurgery - Abstract
IntroductionPatients 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 analysisThe 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 disseminationThe 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 registrationThis 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.
- Published
- 2017