Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
Key facts
- Who runs it
- Fundación Neumologica Colombiana
- Where
- Bogotá and Chía, ColombiaSee the 2 sites
- Trial code
- Status
- Recruiting
- People taking part
- 117 people, planned
- Started
- 1 Jan 2018
- Expected to end
- 30 Nov 2026
- Type of study
- Interventional, 2 groups
- Treatments tested
- Laryngopharyngeal sensory test
- Record updated
- 8 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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 take part
- 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
- 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)
- 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)
- Bleeding diathesis
- Glasgow coma scale below of 15 (to avoid confusion with involvement of laryngopharyngeal reflexes due to neurological disease accompanied by decreased level of consciousness)
- 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)
- 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)
- 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)
- Basal awake oxygen saturation by pulse oximetry below 88%
- Not agree to participate in the study
- Baseline polysomnography that does not meet validity criteria to be interpreted (according to the American Academy of Sleep Medicine)
- More than 5% of total apnoea events being of central origin
- Traumatic brain injury in the last three months or more than three month with neurological sequelae
- Patient's inability to cooperate during the examination (to avoid measurement error caused by the lack of cooperation of the patient)
Where in Colombia
- Fundacion Neumologica ColombianaBogotá, ColombiaContact: Luis F Giraldo-Cadavid, MD, PhDTaking people
- Universidad de La SabanaChía, ColombiaContact: Alirio R Bastidas, MD, MScNot yet recruiting
About the trial
What the trial wants to find out
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).
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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.
The 2 groups in the trial
- Expert raterOther group
Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests.
Treatment: Laryngopharyngeal sensory test
- Non-expert raterOther group
* 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.
Treatment: Laryngopharyngeal sensory test
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 8 January 2026