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

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions

Larynx
Sensory Disorder
Sleep Apnea - Obstructive

Type

Interventional

Phase

Not Applicable

Design

Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Subjects participating in the inter-rater reliability evaluation will be evaluated by two raters, an expert and a non-expert rater, each rater performing two measurements of laryngopharyngeal sensory thresholds (ST) two times at each side (right and left) of the corresponding laryngopharyngeal structure. All other subjects, participating in the accuracy evaluation, will be evaluated by only one expert rater who will perform three measurements of laryngopharyngeal ST per subject. The varying degrees of rater experience aims to reproduce common scenarios when a new technique (like the measurement of laryngopharyngeal mechanosensitivity) is introduced to clinical practice. The two raters will measure the ST sequentially and in a randomized cross-over design in each subject (the order in which each rater intervenes will be randomized) aiming that the sensory tests be started an equal number of times by an expert rater and non-expert rater.Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The allocation sequence, determining which rater (expert vs non-expert) intervenes first or second, will be concealed using the SNOSE strategy (sequentially numbered opaque sealed envelopes). One of the authors (ARB), who has not competing interests will generate the allocation sequence and conceal it in envelopes. While the first rater measures the sensory thresholds (ST) the second rater will be at a different room for blinding purposes. There will be no communication about the testing results between the two raters nor the staff who are helping the testing performance. To mask the values of the ST, air pulses will be identified by a random combination of three letters instead of by the intensity levels corresponding to the air pulses. The raters will not know the intensity corresponding to each letter combination. At the end of the test, an assistant will replace the letters corresponding to the ST values by the intensity levels of the air pulses in units of force (millinewtons)Primary Purpose: Diagnostic

Participation Requirements

Age: Between 18 years and 125 years
Gender: Both males and females

Description

INTRODUCTION: Obstructive sleep apnea-hypopnea syndrome (OSA) patients might have varying degrees of laryngopharyngeal mechanical hyposensitivity; however, these findings come from studies performed with methods having weak inter-rater reliability and accuracy evidence. The purpose of this study is to validate the measurement of laryngopharyngeal mechanosensitivity in patients with OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER). The LPEER includes an air-pulse generator and an endoscopic laser rangefinder and works coupled to a conventional fiberoptic endoscope. This device generates air-pulses ranging from 0.04 mN to 16.5 mN in order to cover a wide range of laryngopharyngeal reflexes and sensory thresholds. Depending on the reflex or sensory threshold to be explored the LPEER is configured to deliver a sequence of 10 air-pulses of different intensity. METHODS: The study will be prospective, double blinded, and with a randomized and crossover assignment of the raters. Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a sleep laboratory of a tertiary care university hospital. They will undergo a laryngopharyngeal sensory test using the LPEER, which includes measurement of the thresholds for the velopharyngeal, hypopharyngeal and aryepiglottic fold psychophysical sensitivity. 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 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.The discriminative capacity as well as correlations between laryngopharyngeal sensory thresholds and OSA severity indexes will be explored in subgroups of subjects with normal and abnormal sensation. The relationship between sensory thresholds and OSA severity indexes will be explored by linear equations as well as by second- and higher-order polynomial equations. The laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER), could be a new tool for the evaluation and monitoring of laryngopharyngeal sensory involvement in patients with OSA, which, if proved valid, could help to increase the knowledge about the pathophysiological mechanisms of this condition and potentially help finding new therapeutic interventions for OSA. ETHICS: This study will follow the Declaration of Helsinki principles and national legal regulations about research in human subjects. The protocol was approved by the Institutional Review Board of Fundacion Neumologica Colombiana and all recruited subjects will provided a signed informed consent. DISSEMINATION: The results will be disseminated through conference presentations and peer-reviewed publication.

Tracking Information

NCT #

NCT03109171

Collaborators

Universidad de la Sabana
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Investigators

Study Chair: Luis F Giraldo-Cadavid, MD, PhD University of La Sabana; Fundacion Neumologica Colombiana