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

Primary Purpose

Sleep Apnea, Obstructive, Larynx, Sensory Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Laryngopharyngeal sensory test
Sponsored by
Fundación Neumologica Colombiana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring Endoscopy, Lasers, Fiber Optic Technology, Bronchoscopy, Esthesiometer, Mechanoreceptors, Diagnosis, Reflex, Reproducibility of Results, Reliability of Results, Validity of Results, Sensory Thresholds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Sites / Locations

  • Fundacion Neumologica ColombianaRecruiting
  • Universidad de la Sabana

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Expert rater

Non-expert rater

Arm Description

Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests.

Pulmonologist or Otolaryngologist inexperienced in laryngopharyngeal sensory evaluation: who has made minimum 5 and maximum 50 laryngopharyngeal sensory tests. Pulmonologist fellow who has completed the training provided for a Pulmonologist Fellow in bronchoscopy and who has performed minimum 5 and maximum 50 laryngopharyngeal sensory testing.

Outcomes

Primary Outcome Measures

Velopharynx psychophysical sensory threshold
Sensitivity threshold at the velopharynx in millinewtons (mN).
Hypopharynx psychophysical sensory threshold
Sensitivity threshold at the hypopharynx in millinewtons (mN).
Aryepiglottic fold psychophysical sensory threshold
Sensitivity threshold at the aryepiglottic folds in millinewtons (mN).

Secondary Outcome Measures

Apnea Hypopnea Index
Number of apneas and hypopneas per hour reported in polysomnography, according to the American Academy of Sleep Medicine criteria.
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.
T90
Time spent at oxygen saturation below 90% by pulse oximetry
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.

Full Information

First Posted
April 6, 2017
Last Updated
September 22, 2020
Sponsor
Fundación Neumologica Colombiana
Collaborators
Universidad de la Sabana, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
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1. Study Identification

Unique Protocol Identification Number
NCT03109171
Brief Title
Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundación Neumologica Colombiana
Collaborators
Universidad de la Sabana, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Larynx, Sensory Disorder
Keywords
Endoscopy, Lasers, Fiber Optic Technology, Bronchoscopy, Esthesiometer, Mechanoreceptors, Diagnosis, Reflex, Reproducibility of Results, Reliability of Results, Validity of Results, Sensory Thresholds

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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)
Allocation
Randomized
Enrollment
117 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Expert rater
Arm Type
Other
Arm Description
Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests.
Arm Title
Non-expert rater
Arm Type
Other
Arm Description
Pulmonologist or Otolaryngologist inexperienced in laryngopharyngeal sensory evaluation: who has made minimum 5 and maximum 50 laryngopharyngeal sensory tests. Pulmonologist fellow who has completed the training provided for a Pulmonologist Fellow in bronchoscopy and who has performed minimum 5 and maximum 50 laryngopharyngeal sensory testing.
Intervention Type
Other
Intervention Name(s)
Laryngopharyngeal sensory test
Intervention Description
The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
Primary Outcome Measure Information:
Title
Velopharynx psychophysical sensory threshold
Description
Sensitivity threshold at the velopharynx in millinewtons (mN).
Time Frame
15 days
Title
Hypopharynx psychophysical sensory threshold
Description
Sensitivity threshold at the hypopharynx in millinewtons (mN).
Time Frame
15 days
Title
Aryepiglottic fold psychophysical sensory threshold
Description
Sensitivity threshold at the aryepiglottic folds in millinewtons (mN).
Time Frame
15 days
Secondary Outcome Measure Information:
Title
Apnea Hypopnea Index
Description
Number of apneas and hypopneas per hour reported in polysomnography, according to the American Academy of Sleep Medicine criteria.
Time Frame
15 days
Title
Oxygen desaturation index
Description
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
Title
T90
Description
Time spent at oxygen saturation below 90% by pulse oximetry
Time Frame
15 days
Title
Adverse Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis F Giraldo-Cadavid, MD, PhD
Phone
+573106083557
Email
luisf.giraldo@unisabana.edu.co
First Name & Middle Initial & Last Name or Official Title & Degree
Maria A Bazurto, MD
Phone
+577428900
Email
mbazurto@neumologica.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis F Giraldo-Cadavid, MD, PhD
Organizational Affiliation
University of La Sabana; Fundacion Neumologica Colombiana
Official's Role
Study Chair
Facility Information:
Facility Name
Fundacion Neumologica Colombiana
City
Bogotá
State/Province
Bogota
ZIP/Postal Code
110131399
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis F Giraldo-Cadavid, MD, PhD
Phone
+573106083557
Email
lfgiraldo@neumologica.org
First Name & Middle Initial & Last Name & Degree
Maria A Bazurto, MD
Phone
+573105536357
Email
mbazurto@neumologica.org
First Name & Middle Initial & Last Name & Degree
Maria A Bazurto, MD
First Name & Middle Initial & Last Name & Degree
Luis F. Giraldo-Cadavid, MD, PhD
First Name & Middle Initial & Last Name & Degree
Nelson Paéz-Espinel, MD
Facility Name
Universidad de la Sabana
City
Chia
State/Province
Cundinamarca
ZIP/Postal Code
250001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alirio R Bastidas, MD, MSc
Phone
+5718615555
Email
aliriobg@clinicaunisabana.edu.co
First Name & Middle Initial & Last Name & Degree
Claudia M Vanegas, Eng, MSc
Phone
+5718615555
Email
claudia.vanegas@unisabana.edu.co
First Name & Middle Initial & Last Name & Degree
Alirio R Bastidas, MD, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://upperairwaylfgiraldo.wordpress.com/about/
Description
Endoscopic Laryngopharyngeal Sensory Test (ELST) Protocol for the Validation of a Laryngo-Pharyngeal Endoscopic Esthesiometer and Rangefinder (LPEER)

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

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