Sleep Apnea, ObstructiveNCT03109171
Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
A study testing Laryngopharyngeal sensory test in people with Sleep Apnea, Obstructive and Larynx, run by Fundación Neumologica Colombiana at 2 sites in Colombia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive, Larynx, Sensory Disorder
- What is being tested?
- Laryngopharyngeal sensory test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 2 sitesColombia
- Study dates
- 1 Jan 2018to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia2 sites, 2 recruiting
- Recruiting
Fundacion Neumologica Colombiana
Bogotá, Bogota D.C., 110131399
Luis F Giraldo-Cadavid, MD, PhD, +573106083557, lfgiraldo@neumologica.org
Maria A Bazurto, MD, +573105536357, mbazurto@neumologica.org
- Not yet recruiting
Universidad de la Sabana
Chía, Cundinamarca, 250001
Alirio R Bastidas, MD, MSc, +5718615555, aliriobg@clinicaunisabana.edu.co
Claudia M Vanegas, Eng, MSc, +5718615555, claudia.vanegas@unisabana.edu.co
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Larynx, Sensory Disorder
- Being tested
- Laryngopharyngeal sensory test
- Keywords
- Endoscopy, Lasers, Fiber Optic Technology, Bronchoscopy, Esthesiometer, Mechanoreceptors, Diagnosis, Reflex, Reproducibility of Results, Reliability of Results, Validity of Results, Sensory Thresholds
- Medical subject headings
- Sleep Apnea, Obstructive, Laryngeal Diseases, Sensation Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laryngopharyngeal sensory testOther
The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
| Study group | Role | What they receive |
|---|---|---|
| Expert rater | Other | Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests. Receives: Other: Laryngopharyngeal sensory test |
| Non-expert rater | Other | * 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. Receives: Other: Laryngopharyngeal sensory test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Velopharynx psychophysical sensory threshold
Sensitivity threshold at the velopharynx in millinewtons (mN).
Measured: 15 days
Hypopharynx psychophysical sensory threshold
Sensitivity threshold at the hypopharynx in millinewtons (mN).
Measured: 15 days
Aryepiglottic fold psychophysical sensory threshold
Sensitivity threshold at the aryepiglottic folds in millinewtons (mN).
Measured: 15 days
Secondary outcomes (4)
Apnea Hypopnea Index
Number of apneas and hypopneas per hour reported in polysomnography, according to the American Academy of Sleep Medicine criteria.
Measured: 15 days
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.
Measured: 15 days
T90
Time spent at oxygen saturation below 90% by pulse oximetry
Measured: 15 days
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start1 Jan 2018
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Neumologica Colombiana
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de la Sabana, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Principal investigator, Luis F. Giraldo-Cadavid, Fundación Neumologica Colombiana
- Investigators
- Luis F Giraldo-Cadavid, MD, PhD, Study chair, University of La Sabana; Fundacion Neumologica Colombiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109171
- Sponsor's protocol ID
- 201611-22405
- Status last verified
- Jan 2026
- First submitted
- 6 Apr 2017
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miyaji H, Hironaga N, Umezaki T, Hagiwara K, Shigeto H, Sawatsubashi M, Tobimatsu S, Komune S. Neuromagnetic detection of the laryngeal area: Sensory-evoked fields to air-puff stimulation. Neuroimage. 2014 Mar;88:162-9. doi: 10.1016/j.neuroimage.2013.11.008. Epub 2013 Nov 15.
PubMed 24246493Nguyen AT, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005 May;28(5):585-93. doi: 10.1093/sleep/28.5.585.
PubMed 16171271Aviv JE, Martin JH, Sacco RL, Zagar D, Diamond B, Keen MS, Blitzer A. Supraglottic and pharyngeal sensory abnormalities in stroke patients with dysphagia. Ann Otol Rhinol Laryngol. 1996 Feb;105(2):92-7. doi: 10.1177/000348949610500202.
PubMed 8659942Aviv 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.
PubMed 9292613Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.
PubMed 23910433Teramoto S, Sudo E, Matsuse T, Ohga E, Ishii T, Ouchi Y, Fukuchi Y. Impaired swallowing reflex in patients with obstructive sleep apnea syndrome. Chest. 1999 Jul;116(1):17-21. doi: 10.1378/chest.116.1.17.
PubMed 10424498Valbuza 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.
PubMed 21229321Giraldo-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.
PubMed 28341965Giraldo-Cadavid LF, Agudelo-Otalora LM, Burguete J, Arbulu M, Moscoso WD, Martinez F, Ortiz AF, Diaz J, Pantoja JA, Rueda-Arango AF, Fernandez S. Design, development and validation of a new laryngo-pharyngeal endoscopic esthesiometer and range-finder based on the assessment of air-pulse variability determinants. Biomed Eng Online. 2016 May 10;15(1):52. doi: 10.1186/s12938-016-0166-1.
PubMed 27160751Oliveira LA, Fontes LH, Cahali MB. Swallowing and pharyngo-esophageal manometry in obstructive sleep apnea. Braz J Otorhinolaryngol. 2015 May-Jun;81(3):294-300. doi: 10.1016/j.bjorl.2015.03.006. Epub 2015 Mar 30.
PubMed 25921934Chien MY, Wu YT, Lee PL, Chang YJ, Yang PC. Inspiratory muscle dysfunction in patients with severe obstructive sleep apnoea. Eur Respir J. 2010 Feb;35(2):373-80. doi: 10.1183/09031936.00190208. Epub 2009 Jul 30.
PubMed 19643936Tsai YJ, Ramar K, Liang YJ, Chiu PH, Powell N, Chi CY, Lung TC, Wen-Yang Lin W, Tseng PJ, Wu MY, Chien KC, Weaver EM, Lee FP, Lin CM, Chen KC, Chiang RP. Peripheral neuropathology of the upper airway in obstructive sleep apnea syndrome. Sleep Med Rev. 2013 Apr;17(2):161-8. doi: 10.1016/j.smrv.2012.05.005. Epub 2012 Aug 17.
PubMed 22902356Eckert DJ, Lo YL, Saboisky JP, Jordan AS, White DP, Malhotra A. Sensorimotor function of the upper-airway muscles and respiratory sensory processing in untreated obstructive sleep apnea. J Appl Physiol (1985). 2011 Dec;111(6):1644-53. doi: 10.1152/japplphysiol.00653.2011. Epub 2011 Sep 1.
PubMed 21885797Fogel RB, Malhotra A, Shea SA, Edwards JK, White DP. Reduced genioglossal activity with upper airway anesthesia in awake patients with OSA. J Appl Physiol (1985). 2000 Apr;88(4):1346-54. doi: 10.1152/jappl.2000.88.4.1346.
PubMed 10749829Kezirian EJ, Boudewyns A, Eisele DW, Schwartz AR, Smith PL, Van de Heyning PH, De Backer WA. Electrical stimulation of the hypoglossal nerve in the treatment of obstructive sleep apnea. Sleep Med Rev. 2010 Oct;14(5):299-305. doi: 10.1016/j.smrv.2009.10.009. Epub 2010 Jan 29.
PubMed 20116305
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03109171
- Acronym / sponsor ID
- 201611-22405
- Conditions
- Sleep Apnea, Obstructive, Larynx, Sensory Disorder
- Keywords
- Endoscopy, Lasers, Fiber Optic Technology, Bronchoscopy, Esthesiometer, Mechanoreceptors, Diagnosis, Reflex
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 117 participants (estimated)
- Lead sponsor
- Fundación Neumologica ColombianaUniversity, hospital or other
- Collaborators
- Universidad de la Sabana, Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Expert rater | Other | Other: Laryngopharyngeal sensory testPulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests. |
| Non-expert rater | Other | Other: Laryngopharyngeal sensory test* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (18 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laryngopharyngeal sensory testThe sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds | Other | Expert rater, Non-expert rater |
Primary outcome
Velopharynx psychophysical sensory threshold
Time frame: 15 days
Sensitivity threshold at the velopharynx in millinewtons (mN).
Hypopharynx psychophysical sensory threshold
Time frame: 15 days
Sensitivity threshold at the hypopharynx in millinewtons (mN).
Aryepiglottic fold psychophysical sensory threshold
Time frame: 15 days
Sensitivity threshold at the aryepiglottic folds in millinewtons (mN).
4 secondary outcomes
Apnea Hypopnea Index
Time frame: 15 days
Oxygen desaturation index
Time frame: 15 days
T90
Time frame: 15 days
Adverse Events
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 24246493Miyaji H, Hironaga N, Umezaki T, Hagiwara K, Shigeto H, Sawatsubashi M, Tobimatsu S, Komune S. Neuromagnetic detection of the laryngeal area: Sensory-evoked fields to air-puff stimulation. Neuroimage. 2014 Mar;88:162-9. doi: 10.1016/j.neuroimage.2013.11.008. Epub 2013 Nov 15.
- Background: PubMed 16171271Nguyen AT, Jobin V, Payne R, Beauregard J, Naor N, Kimoff RJ. Laryngeal and velopharyngeal sensory impairment in obstructive sleep apnea. Sleep. 2005 May;28(5):585-93. doi: 10.1093/sleep/28.5.585.
- Background: PubMed 8659942Aviv JE, Martin JH, Sacco RL, Zagar D, Diamond B, Keen MS, Blitzer A. Supraglottic and pharyngeal sensory abnormalities in stroke patients with dysphagia. Ann Otol Rhinol Laryngol. 1996 Feb;105(2):92-7. doi: 10.1177/000348949610500202.
- Background: PubMed 9292613Aviv 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.
- Background: PubMed 23910433Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.
- Background: PubMed 10424498Teramoto S, Sudo E, Matsuse T, Ohga E, Ishii T, Ouchi Y, Fukuchi Y. Impaired swallowing reflex in patients with obstructive sleep apnea syndrome. Chest. 1999 Jul;116(1):17-21. doi: 10.1378/chest.116.1.17.
- Background: PubMed 21229321Valbuza 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.
- Background: PubMed 28341965Giraldo-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.
- Background: PubMed 27160751Giraldo-Cadavid LF, Agudelo-Otalora LM, Burguete J, Arbulu M, Moscoso WD, Martinez F, Ortiz AF, Diaz J, Pantoja JA, Rueda-Arango AF, Fernandez S. Design, development and validation of a new laryngo-pharyngeal endoscopic esthesiometer and range-finder based on the assessment of air-pulse variability determinants. Biomed Eng Online. 2016 May 10;15(1):52. doi: 10.1186/s12938-016-0166-1.
- Background: PubMed 25921934Oliveira LA, Fontes LH, Cahali MB. Swallowing and pharyngo-esophageal manometry in obstructive sleep apnea. Braz J Otorhinolaryngol. 2015 May-Jun;81(3):294-300. doi: 10.1016/j.bjorl.2015.03.006. Epub 2015 Mar 30.
- Background: PubMed 19643936Chien MY, Wu YT, Lee PL, Chang YJ, Yang PC. Inspiratory muscle dysfunction in patients with severe obstructive sleep apnoea. Eur Respir J. 2010 Feb;35(2):373-80. doi: 10.1183/09031936.00190208. Epub 2009 Jul 30.
- Background: PubMed 22902356Tsai YJ, Ramar K, Liang YJ, Chiu PH, Powell N, Chi CY, Lung TC, Wen-Yang Lin W, Tseng PJ, Wu MY, Chien KC, Weaver EM, Lee FP, Lin CM, Chen KC, Chiang RP. Peripheral neuropathology of the upper airway in obstructive sleep apnea syndrome. Sleep Med Rev. 2013 Apr;17(2):161-8. doi: 10.1016/j.smrv.2012.05.005. Epub 2012 Aug 17.
- Endoscopic Laryngopharyngeal Sensory Test (ELST) Protocol for the Validation of a Laryngo-Pharyngeal Endoscopic Esthesiometer and Rangefinder (LPEER)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luis F Giraldo-Cadavid, MD, PhD study chair
University of La Sabana; Fundacion Neumologica Colombiana
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laryngopharyngeal sensory test in people with Sleep Apnea, Obstructive and Larynx, run by Fundación Neumologica Colombiana at 2 sites in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis F Giraldo-Cadavid, MD, PhD (+573106083557, luisf.giraldo@unisabana.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Velopharynx psychophysical sensory threshold (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03109171, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.