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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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Colombia
Fundacion Neumologica Colombiana
RECRUITING
Bogotá
Universidad de la Sabana
NOT_YET_RECRUITING
Chía
Contact Information
Primary
Luis F Giraldo-Cadavid, MD, PhD
luisf.giraldo@unisabana.edu.co
+573106083557
Backup
Maria A Bazurto, MD
mbazurto@neumologica.org
+577428900
Time Frame
Start Date: 2018-01-01
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 117
Treatments
Other: Expert rater
Pulmonologist or Otolaryngologist with experience in laryngopharyngeal sensory evaluation: who has made more than 50 laryngopharyngeal sensory tests.
Other: 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.
Authors
Diana C Concha-Galan
Related Therapeutic Areas
Sponsors
Collaborators: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Universidad de la Sabana
Leads: Fundación Neumologica Colombiana

This content was sourced from clinicaltrials.gov

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