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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2021
  • participants needed
    117
  • sponsor
    Fundación Neumologica Colombiana
Updated on 25 January 2021
polysomnography

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.

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.

Details
Condition Sensory disturbance, Laryngeal disorder, Larynx, Obstructive sleep apnea, sensory disturbances, sensory disorder, sensory disorders, benign neoplasm of the larynx
Treatment Laryngopharyngeal sensory test
Clinical Study IdentifierNCT03109171
SponsorFundación Neumologica Colombiana
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Obstructive sleep apnea or Laryngeal disorder or Larynx or Sensory disturbance?
Do you have any of these conditions: Sensory disturbance or Obstructive sleep apnea or Larynx or sensory disorders or sensory disorder or benign neoplasm of the larynx or sensory disturba...?
Patients being 18 years old or more referred to the sleep laboratory of a tertiary care university hospital for a baseline polysomnography for suspected OSA

Exclusion Criteria

Anticoagulation (though not a contraindication for the endoscopic laryngopharyngeal sensory test, anticoagulation is an exclusion criteria for this validation study in order to keep it a minimal-risk study)
Bleeding diathesis
Basal awake oxygen saturation by pulse oximetry below 88%
Not agree to participate in the study
Glasgow coma scale below of 15 (to avoid confusion with involvement of laryngopharyngeal reflexes due to neurological disease accompanied by decreased level of consciousness)
Baseline polysomnography that does not meet validity criteria to be interpreted (according to the American Academy of Sleep Medicine)
Baseline polysomnography performed more than 15 days before the sensory testing. Ordinarily, the sensory testing will be performed the same day or the next day of baseline polysomnography
More than 5% of total apnoea events being of central origin
History of maxillofacial or pharyngeal surgery (to avoid confusion with involvement of laryngopharyngeal reflexes due to surgery in this region)
Laryngopharyngeal tract malignancies (to avoid confusion with involvement of laryngopharyngeal reflexes due to tumours)
Central Nervous System (CNS) surgery in the last three months or that has left neurological sequelae (to avoid confusion with involvement of laryngopharyngeal reflexes due to sequelae of CNS surgery)
Traumatic brain injury in the last three months or more than three month with neurological sequelae
History of active neuromuscular disease that affects the muscles of head and neck or with sequels present at the time of the sensory testing (to avoid confusion with involvement of laryngopharyngeal reflexes due to neuromuscular disease)
History of cerebrovascular disease (to avoid confusion with dysphagia or sensory compromise secondary to cerebrovascular disease)
Diabetes (to avoid confusion with diabetic neuropathy that compromises the laryngopharyngeal region)
Chronic use of systemic corticosteroids at a dose greater or equal to 20 mg per day of prednisone or equivalent (to avoid confusion with steroid myopathy that compromises the laryngopharyngeal region)
Upper respiratory tract infection within 15 days prior to the testing (to avoid confusion with neuropathy associated with respiratory viral disease that compromises the laryngopharyngeal region)
Patient's inability to cooperate during the examination (to avoid measurement error caused by the lack of cooperation of the patient)
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