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Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
Sponsor: Fundación Neumologica Colombiana
Summary
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.
Official title: Accuracy of the Sensory Test Performed Using the Laryngopharyngeal Endoscopic Esthesiometer and Rangefinder in Patients With Suspected Obstructive Sleep Apnoea Hypopnea (OSA): a Prospective Double-blinded, Randomised, Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
117
Start Date
2018-01-01
Completion Date
2026-11-30
Last Updated
2026-01-08
Healthy Volunteers
Yes
Interventions
Laryngopharyngeal sensory test
The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
Locations (2)
Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., Colombia
Universidad de la Sabana
Chía, Cundinamarca, Colombia