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RECRUITING
NCT03109171
NA

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

Sponsor: Fundación Neumologica Colombiana

View on ClinicalTrials.gov

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

OTHER

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