NCT03109171 Accuracy of the Sensory Test Using the Laryngopharyngeal Endoscopic Esthesiometer in Obstructive Sleep Apnea
| NCT ID | NCT03109171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Neumologica Colombiana |
| Condition | Sleep Apnea, Obstructive |
| Study Type | INTERVENTIONAL |
| Enrollment | 117 participants |
| Start Date | 2018-01-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 117 participants in total. It began in 2018-01-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Luis F Giraldo-Cadavid, MD, PhD
STUDY CHAIR
University of La Sabana; Fundacion Neumologica Colombiana
Frequently Asked Questions
Who can join the NCT03109171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sleep Apnea, Obstructive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03109171 currently recruiting?
Yes, NCT03109171 is actively recruiting participants. Contact the research team at luisf.giraldo@unisabana.edu.co for enrollment information.
Where is the NCT03109171 trial being conducted?
This trial is being conducted at Bogotá, Colombia, Chía, Colombia.
Who is sponsoring the NCT03109171 clinical trial?
NCT03109171 is sponsored by Fundación Neumologica Colombiana. The principal investigator is Luis F Giraldo-Cadavid, MD, PhD at University of La Sabana; Fundacion Neumologica Colombiana. The trial plans to enroll 117 participants.