Accuracy of the Sensory Test Performed Using the Laryngopharyngeal Endoscopic Esthesiometer and Rangefinder in Patients With Suspected Obstructive Sleep Apnea Hypopnea: a Prospective Double-blinded, Randomised, Pilot Study

What this Trial Is About

Researchers are studying the accuracy of a new device called the laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) to measure throat sensitivity in patients suspected of having obstructive sleep apnea (OSA). This prospective, double-blinded, randomized crossover trial aims to validate this device's measurements by comparing them to standard sleep study results. The study focuses on understanding sensory differences in patients with mild, moderate, and severe OSA and improving knowledge about OSA’s underlying mechanisms. The study involves patients referred for a baseline sleep test who will undergo a sensory test using the LPEER, which delivers air pulses of varying intensity to specific throat areas: the velopharynx, hypopharynx, and aryepiglottic folds. Experienced and less experienced pulmonologists or otolaryngologists will perform these tests to assess measurement reliability. The study design includes randomized crossover assignment of raters to evaluate intra- and inter-rater agreement and diagnostic accuracy through detailed statistical analyses. Participants will attend the sleep laboratory where they will receive the sensory test alongside their routine sleep study. Researchers will measure sensory thresholds at three throat sites and collect data related to sleep apnea severity, oxygen levels, and any adverse events. The study will last up to 15 days for each participant, during which safety and test accuracy will be closely monitored. Results will help determine the usefulness of LPEER for future clinical evaluation and monitoring of OSA patients.

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