Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
NCT ID: NCT03109171
Last Updated: 2026-01-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
117 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-01
Study Completion Date
2026-11-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Sleep Apnea, Obstructive
Larynx
Sensory Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
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.
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.
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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)
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)
Study Groups
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Expert rater
Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests.
Group Type
OTHER
Laryngopharyngeal sensory test
Intervention Type
OTHER
The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
Non-expert rater
* 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.
Group Type
OTHER
Laryngopharyngeal sensory test
Intervention Type
OTHER
The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
Interventions
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Laryngopharyngeal sensory test
The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
Intervention Type
OTHER
Eligibility Criteria
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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
* 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).
* 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).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Universidad de la Sabana
OTHER
Sponsor Role
collaborator
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
OTHER_GOV
Sponsor Role
collaborator
Fundación Neumologica Colombiana
OTHER
Sponsor Role
lead
Responsible Party
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Luis F. Giraldo-Cadavid
Pulmonologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Luis F Giraldo-Cadavid, MD, PhD
Role: STUDY_CHAIR
University of La Sabana; Fundacion Neumologica Colombiana
Locations
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Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., Colombia
Site Status
RECRUITING
Universidad de la Sabana
Chía, Cundinamarca, Colombia
Site Status
NOT_YET_RECRUITING
Countries
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Colombia
Central Contacts
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Facility Contacts
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References
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Aviv JE, Sacco RL, Mohr JP, Thompson JL, Levin B, Sunshine S, Thomson J, Close LG. Laryngopharyngeal sensory testing with modified barium swallow as predictors of aspiration pneumonia after stroke. Laryngoscope. 1997 Sep;107(9):1254-60. doi: 10.1097/00005537-199709000-00018.
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BACKGROUND
Valbuza JS, de Oliveira MM, Zancanella E, Conti CF, Prado LB, Carvalho LB, do Prado GF. Swallowing dysfunction related to obstructive sleep apnea: a nasal fibroscopy pilot study. Sleep Breath. 2011 May;15(2):209-13. doi: 10.1007/s11325-010-0474-9. Epub 2011 Jan 13.
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Giraldo-Cadavid LF, Burguete J, Rueda F, Galvis AM, Castaneda N, Agudelo-Otalora LM, Moscoso WD, Paez N, Fernandez S. Reliability of a laryngo-pharyngeal esthesiometer and a method for measuring laryngo-pharyngeal mechano-sensitivity in a prospectively recruited cohort of patients. Eur Arch Otorhinolaryngol. 2017 Jul;274(7):2861-2870. doi: 10.1007/s00405-017-4536-5. Epub 2017 Mar 24.
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Aviv JE, Martin JH, Keen MS, Debell M, Blitzer A. Air pulse quantification of supraglottic and pharyngeal sensation: a new technique. Ann Otol Rhinol Laryngol. 1993 Oct;102(10):777-80. doi: 10.1177/000348949310201007.
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Cunningham JJ, Halum SL, Butler SG, Postma GN. Intraobserver and interobserver reliability in laryngopharyngeal sensory discrimination thresholds: a pilot study. Ann Otol Rhinol Laryngol. 2007 Aug;116(8):582-8. doi: 10.1177/000348940711600805.
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Kimoff RJ, Sforza E, Champagne V, Ofiara L, Gendron D. Upper airway sensation in snoring and obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Jul 15;164(2):250-5. doi: 10.1164/ajrccm.164.2.2010012.
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Aviv JE, Murry T, Zschommler A, Cohen M, Gartner C. Flexible endoscopic evaluation of swallowing with sensory testing: patient characteristics and analysis of safety in 1,340 consecutive examinations. Ann Otol Rhinol Laryngol. 2005 Mar;114(3):173-6. doi: 10.1177/000348940511400301.
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BACKGROUND
Giraldo-Cadavid LF, Bastidas AR, Padilla-Ortiz DM, Concha-Galan DC, Bazurto MA, Vargas L. Accuracy and reliability of the sensory test performed using the laryngopharyngeal endoscopic esthesiometer and rangefinder in patients with suspected obstructive sleep apnoea hypopnoea: protocol for a prospective double-blinded, randomised, exploratory study. BMJ Open. 2017 Aug 21;7(8):e015235. doi: 10.1136/bmjopen-2016-015235.
Reference Type
DERIVED
Related Links
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https://upperairwaylfgiraldo.wordpress.com/about/
Endoscopic Laryngopharyngeal Sensory Test (ELST) Protocol for the Validation of a Laryngo-Pharyngeal Endoscopic Esthesiometer and Rangefinder (LPEER)
Other Identifiers
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201611-22405
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
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