Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea

This is a prospective double blinded randomized crossover controlled trial aiming at validating the measurement of laryngopharyngeal mechanosensitivity in patients with suspected OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER). Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a university hospital sleep laboratory. Intra- 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 evaluate plotting Receiver-operating-characteristic-curves (ROC-curves) using as reference standard basal polysomnogram. The sensory threshold values for patients with mild, moderate, and severe OSA, will be determined and compared using ANOVA or Kruskal Wallis test, depending on the distribution of the variables.

NCT Number	NCT03109171
Lead Sponsor	Fundación Neumologica Colombiana Collaborators: Universidad de la Sabana, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Conditions	Sleep Apnea, Obstructive, Larynx, Sensory Disorder
Enrollment	117 participants
Start Date	2018-01-01
Primary Completion	2026-09-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-08