Measuring throat sensation with an endoscopic esthesiometer in people with obstructive sleep apnea
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 test tries to see if a new endoscopic device can reliably measure throat (laryngopharyngeal) sensation in adults referred for suspected obstructive sleep apnea.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 117 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Neumologica Colombiana Academic / other |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Bogotá, Bogota D.C. and 1 other locations) |
| Trial ID | NCT03109171 on ClinicalTrials.gov |
What this trial studies
This is a prospective, double-blinded, randomized crossover study using a laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER) that delivers calibrated air-pulses to measure sensory thresholds at the velopharynx, hypopharynx, and aryepiglottic folds. Adult patients referred for baseline polysomnography at two tertiary sleep centers will undergo LPEER testing, with raters crossed and blinded to randomize order. Reliability will be quantified with Bland-Altman plots, intraclass correlation coefficients, and correlation coefficients, while diagnostic accuracy will be analyzed by ROC curves using the baseline polysomnogram as the reference standard. Sensory thresholds will be compared across mild, moderate, and severe OSA groups using ANOVA or nonparametric equivalents depending on data distribution.
Who should consider this trial
Good fit: Adults (18+) referred to the participating tertiary sleep laboratories for a baseline polysomnography because OSA is suspected are eligible.
Not a fit: People on anticoagulation, with bleeding diathesis, resting oxygen saturation <88%, altered consciousness (GCS <15), or an invalid or outdated baseline polysomnogram are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, this could provide a reliable bedside measure of laryngopharyngeal sensitivity that helps phenotype OSA and guide targeted management.
How similar studies have performed: Previous studies have suggested laryngopharyngeal hyposensitivity in OSA but used methods with weak reliability, so the LPEER approach is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bogotá, Bogota D.C. and 1 other locations
- Fundacion Neumologica Colombiana — Bogotá, Bogota D.C., Colombia (Recruiting)
- Universidad de la Sabana — Chía, Cundinamarca, Colombia (Not_yet_recruiting)
Study contacts
- Study coordinator: Luis F Giraldo-Cadavid, MD, PhD
- Email: luisf.giraldo@unisabana.edu.co
- Phone: +573106083557
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.