Health TrialsbyHealthPanel

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

ConditionsSleep Apnea, ObstructiveLarynxSensory Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Neumologica Colombiana

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Laryngopharyngeal sensory test

    Other intervention

    The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds

Treatment groups

117 Participants
are divided into 2 treatment groups
Group A: Expert raterOther 1 intervention
Group B: Non-expert raterOther 1 intervention

Trial outcomes

Primary outcomes

1

Velopharynx psychophysical sensory threshold

Sensitivity threshold at the velopharynx in millinewtons (mN).

Time frame
15 days
2

Hypopharynx psychophysical sensory threshold

Sensitivity threshold at the hypopharynx in millinewtons (mN).

Time frame
15 days
3

Aryepiglottic fold psychophysical sensory threshold

Sensitivity threshold at the aryepiglottic folds in millinewtons (mN).

Time frame
15 days

Secondary outcomes

1

Apnea Hypopnea Index

Number of apneas and hypopneas per hour reported in polysomnography, according to the American Academy of Sleep Medicine criteria.

Time frame
15 days
2

Oxygen desaturation index

Number of desaturation episodes by pulse oximetry (SpO2%) (\>3% fall in SpO2%) per hour reported in polysomnography, according to the American Academy of Sleep Medicine criteria.

Time frame
15 days
3

T90

Time spent at oxygen saturation below 90% by pulse oximetry

Time frame
15 days
4

Adverse Events

Any adverse event potentially related to the laryngopharyngeal sensory test, including pain, gagging, discomfort, laryngospasm, syncope or pre-syncope, epistaxis, need for observation or referral to emergency room or hospitalization.

Time frame
15 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Neumologica Colombiana

Lead sponsor

Universidad de la Sabana

Collaborator

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

Collaborator

Source ClinicalTrials.gov
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