Sleep Apnea, Obstructive Clinical Trial
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
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.
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.
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